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12 days old

Regulatory Affairs Specialist II

Kelly Services
Warsaw, IN 46582
**Regulatory Affairs Specialist II**


**OVERALL RESPONSIBILITIES:**


The Regulatory Affairs Specialist II is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy line of products. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA, Technical File, Design Dossiers, and Technical Documentation) or internal regulatory assessment documentation. The regulatory specialist is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of DePuy Synthes products for compliance to global regulations and company policies and procedures.


**DUTIES:**


Prepare and/or assist in preparation of regulatory documentation for DePuy devices, including IDE, 510(k), PMA, Technical File, Design Dossier, and Technical Documentation for submission to regional Health authorities. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase.


+ Assist in the preparation of approval documents to support rest of world registrations, such as EU CE marking activities, as required.

+ Review engineering changes to currently marketed products and prepare internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant regulations and guidance.

+ Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance.

+ Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO 13485, previous MDD, MDR, etc.).

+ Perform other duties as assigned.


**PROFESSIONAL EXPERIENCE REQUIREMENTS:**


+ Minimum 2 years of prior regulatory experience in medical devices

+ Knowledge and/or Familiarity of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidances and standards

+ Knowledge of orthopedic implants a plus

+ Familiarity with G10 regulations and guidance a plus

+ Familiarity with electronic submission preparation a plus

+ Excellent written and oral communication skills

+ Ability to handle multiple tasks and be detail oriented


**EDUCATIONAL REQUIREMENTS:**


+ BA/BS Degree required; advanced degree or equivalent work experience preferred


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-05-13 Expires: 2022-06-13

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Regulatory Affairs Specialist II

Kelly Services
Warsaw, IN 46582

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