• Regulatory Affairs Specialist - Med Device

    ManpowerGroup (Arden Hills, MN)


    Manpower Engineering is partnering with a leader in medical device manufacturing for a Regulatory Affairs Specialist.

     

    Job Title: Regulatory Affairs Specialist

     

    Pay: $45 - $55/hour

     

    Duration: 12 month contract to hire

    Job Function Summary:

    The Regulatory Affairs Specialist is responsible for ensuring materials, components, and finished products comply with global regulatory standards

    Primary Duties and Responsibilities:

    1. Ensure company is compliant with global material and substance regulations, including EU REACH (SVHC, Annex XVII), EU RoHS, Conflict Minerals, and California Proposition 65.

    2. Monitor updates to restricted and reportable substance lists (e.g., REACH SVHC, Prop 65 chemicals) and assess impacts on products and materials.

    3. Collect, review, and validate supplier material declarations (e.g., IPC-1752, IMDS, Full Material Declarations).

    4. Work with 3 rd party to gather compliance data from suppliers.

    5. Conduct material risk assessments, exposure evaluations (as applicable for Prop 65), and compliance gap analyses.

    6. Coordinate with Purchasing, Engineering, Quality, and Operations to ensure compliant material selection and product design.

    7. Maintain material compliance records, databases, and technical documentation to support audits, customer inquiries, and regulatory inspections.

    8. Support labeling and warning assessments to ensure requirements are correctly implemented when applicable.

    9. Respond to regulatory authority, customer, and internal compliance inquiries related to material and substance compliance.

    10. Support substance compliance aspects of product development, change management, and supplier qualification.

    Requirements:

    Education:

    + Bachelor’s degree in engineering or related field or equivalent experience..

    Experience:

    + Minimum of five (5) years’ experience in regulatory affairs in a medical device regulated environment.

    + Familiarity with medical device classifications and regulatory pathways

    Skills:

    + Strong working knowledge of regulatory requirements for US, Canada, European Union, and Costa Rica.

    + Excellent communication skills, both written and oral.

    + Ability to review and evaluate scientific and technical data.

    + Ability to communicate problems and solutions with all levels of the organization.

    + Ability to communicate outside the organization, representing the company to customers, and other external sources.

    Benefits:

    • Comprehensive Medical, Dental, and Vision plans.

    • PTO/Vacation

    • Dedicated Career Partner to help you grow and reach your career goals.

    • 401k with Company Match to secure your financial future.

     

    If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

     

    About ManpowerGroup, Parent Company of:** **Manpower, Experis, Talent Solutions, and Jefferson Wells

     

    _ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _–_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

     

    ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.