• Regulatory Affairs Specialist

    Actalent (Maple Grove, MN)


    Job Title: Regulatory Affairs SpecialistJob Description

     

    We are seeking a dedicated Regulatory Affairs Specialist to join our team. This role involves reviewing, editing, and finalizing engineering test reports and other technical deliverables to support regulatory submissions under FDA, EU MDR, and other global frameworks. You will prepare and support U.S. and international regulatory submissions in accordance with applicable medical device regulations and standards.

    Responsibilities

    + Review, edit, and finalize engineering test reports and other technical deliverables to support regulatory submissions under FDA, EU MDR, and other global frameworks.

    + Prepare and support U.S. and international regulatory submissions in accordance with applicable medical device regulations and standards.

    + Partner with engineering and subject-matter experts to identify and resolve regulatory concerns and provide timely, comprehensive responses to agency inquiries.

    + Maintain up-to-date knowledge and surveillance of U.S. and international medical-device regulations to ensure global submission readiness and ongoing compliance.

    + Review and approve documentation change requests, product labeling, and marketing materials for alignment with regulatory requirements.

    + Assess product and manufacturing changes for regulatory impact and ensure appropriate documentation, notification, or approval pathways are followed.

    + Communicate new or revised regulatory requirements to relevant stakeholders and ensure timely implementation.

    + Perform other related duties as assigned to support regulatory compliance and organizational objectives.

    Essential Skills

    + 3-5 years of experience in regulatory affairs, specifically within the medical-device industry.

    + 3 years of experience with PMA/IDE/510(k) applications.

    + Bachelor’s degree in Engineering or a related discipline.

    + Experience with U.S. FDA submissions (IDE, PMA, 510(k)) and international pathways (EU MDR, Health Canada MDL, Japan Shonin) preferred.

    + Strong experience writing, reviewing, editing, and submitting varied types of documentation.

    + Excellent verbal communication skills and ability to effectively communicate at multiple levels.

    + Proficiency in developing concise test reports.

    Additional Skills & Qualifications

    + Strong proficiency in authoring, reviewing, and editing technical and regulatory documentation.

    + Advanced proficiency in Microsoft Office Suite and document-publishing tools used for regulatory submissions.

    + Excellent organizational and prioritization skills.

    + Ability to manage multiple concurrent projects in a fast-paced environment.

    + Ability to work independently while collaborating effectively across functions.

    + Strong attention to detail and accuracy, with the ability to identify and resolve discrepancies.

    + Ability to travel up to 10%.

    Work Environment

    The position is 100% onsite with some flexibility. The work environment is dynamic, requiring the ability to manage multiple projects simultaneously in a fast-paced setting.

     

    Job Type & Location

     

    This is a Permanent position based out of Maple Grove, MN.

    Pay and Benefits

    The pay range for this position is $100000.00 - $135000.00/yr.

     

    Stock Options. 10-15% bonus potential based on SMART goals. Full Benefit Plan.

     

    Workplace Type

     

    This is a fully onsite position in Maple Grove,MN.

     

    Application Deadline

     

    This position is anticipated to close on Nov 21, 2025.

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

     

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.