Home

Center Valley, Pennsylvania, Aesculap Implant Systems Sr. Regulatory Affairs Spec. US-PA-Center Valley Job ID:  2021-17613 Type:  Regular Full-Time # of Openings:  1 Category:  Regulatory Aesculap Implant Systems Overview Aesculap Implant Systems, LLC, a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients' lives. Responsibilities Position Summary: This position is responsible for developing regulatory strategies for new / modified medical devices, preparation of market applications, and review of regulatory documentation/strategies.   Responsibilities: Essential Duties Develops regulatory strategies for product registration to ensure early product approval. Gathers and researches the necessary information for inclusion into product applications. Writes 501(k)'s IDE'S, PMA'S and follows up with FDA to ensure clearances / approval. Resolves regulatory issues and develops solutions to a variety of problems of moderate scope and complexity. Keeps abreast of FDA events and competitive products. Lists products with the FDA listing Branch. Responds to FDA inquiries regarding product listings. Participates in the development, review and approval of product labeling. Reads legal documents and federal regulations and interprets essential elements for application to Aesculap. Audits regulatory records and reports. Communicates through written and oral means; in face to face contact, meetings and phone discussions. Writes technical documents. Supports postmarket activities required to launch new products (eg, load sheets) Review and approve advertising and promotional items to ensure regulatory compliance. Assimilates information from a variety of sources and organize information into a logical, presentable format. Works under minimal supervision, with benefit of previous regulatory experience. Reads drawings/blueprints. Must comply with applicable ISO and FDA regulations as stated in Quality Manual Must embody the Company's Vision, Mission and Values Expertise: Knowledge & Skills Secondary or peripheral job functions: Performs other duties or special projects as assigned by the manager of this position. Makes travel plans and schedule meetings, as necessary May participate in back room during an FDA inspections Supervisory Responsibilities: N/A Qualifications Expertise: Qualifications-Experience/Training/Education/Etc Required: Bachelor's degree in life sciences or related field, preferred with 5-7 years' experience or a minimum of 12 years equivalent work experience in the Regulatory environment. Must have experience authoring a minimum of ten (10) submissions or equivalent experience Professional certification(s) highly desirable (RAC Certification) Knowledge of US Medical Device law, Quality Systems Regulations and compliance. Able to analyze and develop strategies for regulatory submission with minimal supervision. PC experience is required and proficiency in Office, Adobe, SAP, etc. Requires strong written, oral, interpersonal, group, and telephone communication skills. Must be detail-oriented and highly organized. Analytical skills needed to conduct research, analyze data and write recommendations. Some domestic and international travel is required. Organizes work and juggles multiply priorities; organize thought processes. Ability to work and problem solve both independently and within a team. Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Desired: N/A While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.   B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.   Apply Here PI131339802

Allentown, Pennsylvania, Role: GMP (OTC/Drug, Dietary Supplement, Cosmetics, Non-Regulated, Warehouse/Distribution, Medical Device, Food)/SQF Auditor - This is a Remote position.   Primary Task (Project Based): As assigned will perform and manage GMP(CFR)/SQF/Quality System/Supplier Management audits at facilities designated by various clients. (21 CFR 210/211, 21 CFR 111, 21 CFR 820) Performs on-site reviews of the Client’s Quality System documents and/or records to assist in determining the level of compliance with GMP (CFR)/SQF/Quality System/Supplier Management requirements. Audit on-floor Quality System processes to determine compliance to CFR requirements and correlation to QS written procedures. Represents the audit team to the Client and/or supply site management. Executes audits effectively and efficiently using tools provided. Assures that audit reports and results are produced to meet quality and timeliness standards. Follows appropriate company administrative, personnel, confidentiality, business ethics, conflict of interest and safety policies and procedures. Keeps the Field Operations Supervisor informed verbally and in writing of activities and problems within assigned areas of responsibility. Conduct reviews of Corrective and Preventive forms used by audited sites, in regards to root cause and proposed actions. Coordinates, leads, and directs audit team activities and reporting (as applicable). When assigned, perform Technical Reviews for GMP audits executed independently by other auditors per company policies and within defined time frames. Keeps abreast of current CFR (21 CFR 210/211, 21 CFR 111, 21 CFR 820)/SQF and program requirements. Complies with applicable internal auditing requirements and other appropriate directives. Participates on various professional technical committees where applicable.       Requirements: Four years related work experience in manufacturing or retail sectors in technical, supply chain, retail operations, quality assurance or food safety and or equivalent experience in environmental health, public health or relevant experience. Willingness and ability to travel to other countries, states, regions, provinces and or throughout any assigned or designated country (up to 70 to 80% annually). Excellent written and verbal communication skills in English and if required fully proficient literate in a 2nd language. Excellent oral communication skills; capable of addressing high executive audiences and conduct opening and closing conferences in front of multiple people. Excellent mathematical skills and analytical skills. Creative and innovative thinking to problem solve and streamline processes. Ability to lead a team of auditors during the execution of a project and or specialized audits Proficient in internet navigation, e-mail and PC software such as Microsoft Word, Excel. Interested, Qualified Experts should demonstrate, through suitable means, their knowledge of, and capability of using, the necessary management skills required in the execution of an audit, which are recommended in ISO 19011 and/or the ASQ Fundamentals of Auditing, as follows: effective oral communication skills in asking questions, meeting discussions and in formal settings; effective writing skills to clearly and concisely express observations, findings and conclusions. Interested, Qualified Experts should have the ability to: make decisions in an intelligent, decisive, and authoritative manner; assess situations related to potential problems or conflicts and take appropriate actions; manage an audit, keep the focus of activities within the scope of the audit, and be observant to determine when changes are required; have and maintain a professional image and credentials (as applicable); conduct and control meetings of the on-site audit team, and between the audit team and auditee (as applicable); manage conflict between others and within the audit team (as applicable); coordinate and manage a team of auditors for on-site audits (as applicable) 

Long Island City, New York, 3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow replacement of each individual patient’s parts with tissues designed and created specifically for them. 3DBio has developed unique technology platforms for the development of living tissue implants for therapeutic applications. The  Quality Control Manager  leads all Quality control activities for biologics, devices, and combination products for 3DBio and also manages the respective instrumentation and methodology development. This position supports cGMP release and stability testing of product, transfer and validation of analytical methods. Maintains laboratories in a state of GMP readiness. This SME Manager role will also be required to perform analytical testing. and provides SME analytical testing support including the execution of analytical testing. Responsibilities Establish and Manages a GMP QC biochemistry\biologics and device, laboratory testing environment. Manages the activities of QC in conjunction with supervisory and analytical staff (scheduling and assigns/prioritizes laboratory activities), performs analytical testing where appropriate, and manages inspection and compendial testing on chemical/ products and raw materials. Manages, reviews, and/or performs Quality Control system activities such as in-process, release, and stability testing, information management, investigations, method validation, method transfer, instrument qualification, corrective actions / preventive actions management. Authors and approves SOPs, protocols, reports, and data summaries. Represents QC cross-functionally, provides technical subject matter expertise based on experience with release and stability testing, applies sound scientific judgment based on experience and knowledge of manufacturing and laboratory testing operations. Develops and implements QC-related components of quality management systems aligned with project schedules. Oversees the effective utilization of QMS by laboratory personnel, develops and maintains compliance metrics, and reports to management. Maintains and improves Quality Control GMP compliance and documentation, ensures data integrity of QC data for support of regulatory submissions. Works in collaboration with internal Quality Assurance, Manufacturing and Contract Manufacturing, and Testing Organizations to develop and maintain robust systems for sample tracking, data handling, and reporting of metrics. Proposes and supports continuous improvement projects within QC. Accountable for thorough, well-documented, and timely laboratory deviation/investigation reporting. Assembles and report laboratory metrics outside the QC organization. Effectively utilizes Change Management to develop and execute continuous improvement initiatives within QC. Authors/reviews applicable sections of regulatory documents as needed, support responses to questions from regulatory authorities, and represents QC during inspections. Carries out direct supervisory responsibilities where applicable. Responsibilities include interviewing potential employees; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining. Assures in collaboration with Quality Assurance that applicable employee training is completed and documented. SME in cGMP/ISO vendor audits, as required.   Qualifications Bachelor’s degree in biochemistry, biology, or related disciplines and 7-10 years of experience in a Biologics, Biopharmaceutical, and/or Biotechnology environment; or equivalent combination of education and experience. Prior experience working in a cGMP environment required. Must be proficient with QMS deployed to support GMP quality operations Experience with leading development and implementation of methods used in the testing of Biopharmaceutical products raw materials based on FDA/ICH guidelines and respective compendia. Familiarity with content and providing strategic support for submission of regulatory documents and responses. Excellent oral and written communication, organizational, and interpersonal skills with the ability to multitask while working under restrictive timelines. Ability to effectively manage and perform job responsibilities under minimal supervision.

Falls Church, Virginia, Position Background and Scope This position will lead of a small team to provide direct analytic support to regional decision makers within Navy Medicine. Each region has an independent team, but teams will coordinate with headquarters and across regions to ensure knowledge, learning, and best practices are shared across the organization. Analytic efforts may include modeling, statistical inference, machine learning, data visualization and dashboard development. Position Summary and Responsibilities TBE is seeking an analytics professional to lead a team supporting analytics efforts within Navy Medicine. Responsibilities include, but are not limited to: Work closely with customers, managers, and technical team to define program scope, goals, and deliverables Direct and work with a team to develop long term analysis products Direct and work with a team to respond to ad hoc requests for specific analysis (short term) Prepare and present project communications for customers and key stakeholders Provide leadership for multi-disciplinary teams in a collaborative environment Author technical reports and review team products for consistency and accuracy Qualifications This position requires the ability to obtain a DoD Security Clearance to the level of "Secret" Education and/or Experience Requires a B.S. degree in Industrial Engineering, Operations Research, Mathematics, Statistics, Economics, Data Science, Analytics, or related analytic field. Minimum fifteen (15) years of applicable professional experience, including minimum five (5) years in a supervisory position Superb communication skills with the ability to elicit goals, needs, and outcomes with leaders at all levels across different functions and organizations Highly Desirable Skills and Characteristics M.S. degree in Industrial Engineering, Operations Research, Mathematics, Statistics, Economics, Data Science, Analytics, or related analytic field Demonstrated experience leading analytic projects Demonstrated success in customer-facing roles with frequent stakeholder interactions at all levels 5+ years of direct experience applying operations research, statistics, or data science techniques to develop analysis products Solid foundational knowledge of analytic techniques (statistics, queueing theory, probability, mathematical optimization, machine learning, systems engineering, decision analysis, etc.) Proficiency in one or more programming languages commonly used in analytics (Python, R, Julia etc.) Advanced data visualization experience to clearly communicate relationships among complex data Familiarity with cloud environments (AWS, Azure) Familiarity with software development life cycles and principles Experience working within the Department of Defense Experience working within the Military Health System Citizenship Requirements Due to classified work at the facility and related access restrictions, successful applicants must maintain U.S. Citizenship to allow the person to hold a U.S. Government security clearance.

Sacramento, California, Purpose:   Provides senior level technical expertise for accomplishing major complex civil/structural designs required for new construction and modifications of SMUD’s renewable energy generation projects at greenfield and brownfield sites by applying professional engineering principles in the most efficient, safe and cost-effective manner. This position is a Civil-Service position with a salary range of: $120,273 - $159,308     Major Duties & Responsibilities Assumes responsibility for coordinating, overseeing, and preparing the more complex civil, structural and architectural designs required for new construction and modifications of SMUD’s transmission, distribution and non-nuclear operating facilities by applying accepted engineering principles in the most efficient, safe and cost effective manner; ensures adherence to established SMUD Safety Program. Prepares civil and structural design plans, specifications, and schedules to assure the structural integrity of the transmission and distribution systems and operating facilities; performs technical review of assigned civil design and construction documents and procedures to assure quality output; prepares design plans and construction specifications according to approved budgets and schedules; obtains field information for designs and performs inspections under field conditions. Prepares engineering bid packages and proposals for construction contracts, equipment/material purchases and professional services; coordinates with Supply Chain Services, Legal, Environmental Services and vendors. Develops project work plans and schedules; directs and approves the work of contracted architects, engineers, and consultants; ensures necessary components, construction and services are completed on schedule, within approved budget and in accordance with contract requirements, and applicable codes, SMUD standards and specifications. Provides and analyzes design and construction project alternatives including preparing schedules, estimates and cost/benefit analysis. Applies professional engineering stamp to designs, calculations, reports and drawings Performs related duties as required. Minimum Qualifications Education:  A Bachelor’s degree from an accredited college or university with major course work in Civil Engineering or a related field. Experience:  5 to 7 years of progressively responsible experience in the design and construction of electric transmission and distribution facilities. Skill To:  Monitor the progress of projects and ensure adherence to established budget constraints; develop work plans, schedules and cost estimates; write technical specifications; prepare bid packages and proposals; negotiate with external representatives on behalf of SMUD; plan, oversee and review the work of others; utilize a personal computer and/or computer terminal, systems and software relevant to the job; use state of the art computer software to design civil/structural/architectural systems and facilities; maintain computer databases for collection, interpretation and reporting of data; read and interpret engineering documents and drawings, plans, diagrams and specifications; assist in planning and implementing system protection enhancements and upgrades; analyze situations, documents and data for conformance to established policy and procedures; gather data from appropriate sources and identify relevant factors; identify the key elements that must be modified to achieve a goal; interpret, analyze and apply pertinent policies, procedures, regulations and requirements; interpret, clarify, understand and analyze verbal/written information and ideas; utilize logic and analysis to identify the advantages and disadvantages of different approaches; ensure adherence to established safety policies, practices and procedures; compile and prepare technical, statistical, analytical and/or oral reports and presentations; operate office equipment including computers and supporting word processing, spreadsheet, and database applications; communicate effectively orally and in writing internally/externally; establish and maintain effective working relationships internally/externally. Knowledge Of:  Methods and techniques of project management; principles and practices of contract and budget administration; procedures and practices for overseeing contractor’s work activities; principles and practices of program evaluation and economic analysis; principles of cost control and project scheduling; theory, principles and practices of civil/structural engineering design for thermal, hydro, wind, and photovoltaic power generating resources and pipelines; theory, principles and regulations governing safety and construction of civil/structural systems and facilities; principles, procedures and practices related to construction/fabrication/installation methods, equipment and materials; computer aided drafting and design software (such as AutoCAD); principles of electrical power generation, transmission and distribution; surveying methods and techniques; methods, equipment and materials related to construction of transmission, distribution and non-nuclear operating facilities; construction codes and applicable safety standards; principles, procedures and practices related to engineering mathematics and statistical analysis techniques; principles, procedures and practices related to engineering economics; techniques and practices for cost benefit analyses; methods and techniques of report preparation and writing; techniques and practices for problem research and resolution; safety policies, practices and procedures; pertinent federal, state, and local codes, laws, and regulations; office procedures, methods, and equipment including computers and applicable software applications such as word processing, spreadsheets, and databases; English usage, spelling, grammar, and punctuation. Desirable Qualifications Experience with power generation related facilities, including utility scale wind, photovoltaic and battery projects, and land development, site investigation, geotechnical principles, soils and soil remediation, drainage and foundations related to those facilities. Licenses/Certificates Professional registration in civil and/or structural engineering in the state of California. Physical Requirements:   The health and wellbeing of our employees and our community is our top priority.  SMUD follows CDC guidance and adheres to all local, county and state orders. To this end, if you are scheduled to come on a SMUD campus, you will need to monitor your health (ensuring your temperature is below 100.4° and you’re free of COVID-19 symptoms), wear a face covering, and adhere to social distancing guidelines. Thank you for your support! Stay safe and well. Additional Posting Info for Candidate Sacramento Municipal Utility District (SMUD) - Who We Are As the nation's sixth-largest community-owned electric service provider, we're proud of our reputation as one of the best places to work in Sacramento. Our employees tell us in our engagement surveys they're "Happy, satisfied and engaged" which helps create a workplace that best serves our customers. Sacramento was named as the 2nd happiest place to work in America by Forbes Magazine. Lake Tahoe, San Francisco and the world-renowned Napa Valley are within easy driving distance of our locations. Our Commitment to Diversity & Inclusion SMUD respects, values and celebrates the unique attributes, characteristics and perspectives that make each person who they are. Diversity and inclusion are guiding principles to deliver a culture that reflects the broader values of the community and our customers. Our Board's policy for Employee Relation sets our commitment to developing and maintaining a high quality, inclusive workplace that engages and inspires employees to commit to SMUD's purpose, vision and values. Why Sacramento, California? The capitol of California, Sacramento is the state's sixth-largest city, and the 35th largest in the U.S. Local universities include California State University, University of the Pacific's McGeorge School of Law, and the University of California, Davis and several competitive community colleges. The UC Davis Medical Center, a world-renowned research hospital, is one of more than a dozen hospitals and shared services centers in the Sacramento region. Part of the agriculturally-rich Central Valley, Sacramento is at the forefront of the farm-to-fork food movement. Northern California is home to some of the country's top technology companies, including Google and LinkedIn, and a multitude of startups in many industries. Sacramento is home to the NBA Kings, the River Cats (AAA baseball), the Republic FC (soccer) and the San Francisco Giants, NBA Warriors and NFL 49er's aren't far away. Sacramento offers an affluent liberal arts community with Broadway, Mondavi Center, Crocker Museum and summer musical theater to name a few. To apply, please visit: smud.org/careers