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Regulatory Affairs Specialist, Medical Device

Company: Kelly Services
Location: Warsaw
Posted on: November 22, 2021

Job Description:

Kelly Science & Clinical is currently seeking a **Remote Regulatory Affairs Specialist** for a long-term engagement with one of our Global Med Device clients
*****This role is fully remote*****
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee, you may be eligible for Medical, Dental, Vision, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
**Responsibilities** :
The Regulatory Affairs Specialist is responsible for regulatory activities to support new, modified and currently marketed medical devices in the company's 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 company products for compliance to global regulations and company policies and procedures.
Prepare and/or assist in preparation of regulatory documentation for company 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.
**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
BA/BS Degree required; advanced degree or equivalent work experience preferred
**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 interests-it's 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, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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. ()

Keywords: Kelly Services, South Bend , Regulatory Affairs Specialist, Medical Device, Healthcare , Warsaw, Indiana

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