1+ months

Regulatory Affairs Specialist (Medical Device)

Kelly Services
Kelly Science & Clinical is currently hiring several **Remote Regulatory Affairs Specialist** with IVD experience to support one of our Global Med Device clients out of Minnesota.

*****Remote position*****

This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 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.


Interprets federal/state/international regulations as they apply to our products, processes, and/or procedures advises on the impact of regulations, devises strategies for compliance, and liaison with regulatory bodies.

Investigates and resolves compliance problems, questions, and complaints.

Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes.

Prepare regulatory submissions for new products and/or changes to existing products.

Executes appropriately on product recalls. Respond to regulatory agency inquiries.

Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.

**Job Description**

The Regulatory Affairs Specialist position is an individual contributor and subject-matter-expert responsible for creating and executing regulatory submissions for pre-market activities. This individual contributor will manage global regulatory submission initiatives, working with cross-functional teams as appropriate.

Must be a collaborative facilitator, building consensus while championing global regulatory initiatives for projects. Providing pre-market regulatory initiatives for immunoassay devices, ensuring the development and implementation of advanced and aggressive regulatory strategies.

Author pre-market submissions, including 510(k)s and PMA supplements to the U.S. FDA in alignment with pre-market strategies.

Create / Manage Technical Files in compliance with IVDD and IVDR. Work with international colleagues on establishing design dossiers for their intended market.

**Education/Experience Requirements**

Must possess a bachelors degree

Subject matter expertise in regulatory affairs for medical devices, in-vitro diagnostics experience is a plus

Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devices and preferably IVD (in-vitro diagnostics)

Experience in registration and commercialization of medical device and diagnostic products

Possess a broad knowledge of surrounding areas including Reagent Manufacturing, Development, Laboratory equipment with hardware and software attributes.

Demonstrated track record of developing organizational capability.

Global experience leading and/or participating in cross-functional teams

Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g., RAC, CLIA, Six Sigma, Lean Principles)

**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. (


Posted: 2021-04-12 Expires: 2021-06-03

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Regulatory Affairs Specialist (Medical Device)

Kelly Services

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