1+ months

Regulatory Affairs Specialist II

Kelly Services
Trenton, NJ 08629
**Kelly LifeScience & Clinical is currently seeking a** **Remote Regulatory Affairs Specialist II** **for a long-term engagement at one of our Global Med Device customers.**

**Remote position, however, the customer would like for applicants to be on EST zone.**

**This role is a full-time, fully benefitted position. As a Kelly employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. Youll also be eligible for paid time off, including holiday, vacation, and sick/personal time.**

**Overall Responsibilities:**

**The Regulatory Affairs Specialist II is responsible for regulatory activities to support new, modified and currently marketed medical devices in the 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 companys products for compliance to global regulations and company policies and procedures.**


**Prepare and/or assist in preparation of regulatory documentation for 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:**

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

**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**

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

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**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. 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.



Posted: 2020-10-28 Expires: 2020-12-12

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Regulatory Affairs Specialist II

Kelly Services
Trenton, NJ 08629

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