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Regulatory Affairs Specialist** **_(NO C2C OR THIRD PARTY)_

+ **Location:** Chaska, Minnesota (55318)

+ **Duration:** 6 month – Estimated to end 5/2026 (contract extension potential and internal hire possibilities)

+ **Type** : W2 contract (NO C2C OR THIRD PARTY)

+ **Pay:** Negotiable depending on direct-related experience

+ **Work Authorization:** Must be currently in the United States with active employment authorization documents **without CURRENT sponsorship transfer** requirements.

If you thrive in a fast-paced role and want to contribute to a world-class Regulatory Affairs organization—read on.

Top 3 Must Have Skills:

+ Understanding of IVDR regulations and registration process

+ Understanding of Design Change Process and applicable quality and regulatory requirements

+ Health Canada and EU submission experience

Job Summary:

Individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for post-market activities. This role is responsible for managing regulatory initiatives and working with third parties as appropriate. Build consensus while championing global regulatory initiatives for projects. This position will lead and support change to legal manufacturer designation for company products.

Primary responsibilities include:

+ Evaluation, coordination, preparation and implementation of post-market regulatory activities and design change evaluations.

+ Supports regulatory strategy for new product development activities and applicable submissions or registrations.

+ Manage IVDR Technical Files in compliance

+ Advise business teams to consider the impact of current or emerging regulatory issues, works with colleagues globally to facilitate and ensure company practices are consistent with the corporate regulatory risk posture.

+ Ensure sound post-market product regulatory strategies including minimizing the risk of negative post-market submissions needed for design changes, such as agency review delays.

Requirements of the job include:

+ Bachelor's Degree with 3+ years of experience in Life Sciences or a Master's Degree with 1+ Years of experience in Life Sciences

+ Subject matter expertise in registration and commercialization of in vitro diagnostic medical devices

+ Demonstrated experience leading design change teams for RA.

_Preferred:_

+ Demonstrated knowledge and understanding of regulations and guidelines governing in-vitro diagnostics.

+ Strong Health Canada, and EU submission experience

**Important information:** To be immediately considered, please send an updated version of your resume to [email protected].

_*** (Kelly does not expense relocation/interview costs)**_

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.