Regulatory Affairs Specialist

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PMT Corporation

Regulatory Affairs Specialist

Chanhassen, MN
Full Time
Paid
  • Responsibilities

    Find Fulfillment in Work Every Day! We Offer Careers that Make a Difference.

    PMT Corporation, located in Chanhassen, Minnesota, is known for manufacturing and distributing high end, innovative products within the Orthopedic, Neurosurgery, and Plastic Surgery markets. Our workplace is a community of innovators who are passionate about creating an impact. We recognize that the collective power of our team is what propels us forward. Together, we celebrate successes, learn from challenges, and continuously evolve in our pursuit of excellence.

    Join us at PMT Corporation if you're ready to be a part of a collaborative, idea-driven, and communicative environment. Your innovation matters, and together, we can continue to shape the future of the medical device industry.

    REGULATORY AFFAIRS SPECIALIST OVERVIEW:

    The Quality and Regulatory department supports the registration and compliance of PMT Corporation’s products in the U.S. and for over 100 distributors worldwide. The Regulatory Affairs Specialist will focus on assisting with maintaining product compliance with FDA/MDSAP, ISO, and MDD/MDR requirements. We are looking for an excellent communicator and highly organized individual to join our team on-site with an 8:00am – 4:30 pm shift time.

    DUTIES AND RESPONSIBILITIES OF THE REGULATORY AFFAIRS SPECIALIST:

    • Assess regulatory requirements as well as develop procedures and strategies for maintaining compliance.
    • Maintenance of FDA/MDSAP, ISO, and MDD/MDR compliance
    • Work with Engineering and Quality Departments in product development to ensure compliance throughout design and manufacturing processes
    • Review Engineering Change Orders (ECOs) relating to design, engineering, or manufacturing
    • Work directly with Internal Auditors and Quality Managers on compliance related matters
    • Maintain positive relationships and interact directly with External Auditors and Regulatory Agencies at the reviewer level
    • Interact with Regulatory Departments for International Distributors to assist in registrations and license and certificate renewals
    • Provide support and leadership on development projects and regulatory issues to ensure timely submissions for market clearance
    • Prepare U.S. and International submissions for new products or product changes in a timely manner
    • Other duties as assigned

    QUALIFICATIONS OF THE REGULATORY AFFAIRS SPECIALIST:

    • Bachelor’s degree in Science, Regulatory Affairs, Engineering, or other related field
    • Minimum 2 years of experience in Regulatory Affairs in Health Sciences, preferably Medical Devices
    • Regulatory Submission experience with 510Ks, notified bodies, or international MOH agencies
    • Knowledge of regulatory process for U.S. and EU, experience in other countries highly preferred
    • Highly proficient attention to detail and extremely organized
    • Strong work ethic and able to consistently exceed expectations
    • Excellent communication and time management skills
    • Proficient in Microsoft Office Suite and Adobe
    • Able to work individually and in a team setting to accomplish goals and deadlines
    • Able to pass a pre-employment Background and Drug Screening

    PMT is an Equal Opportunity Employment

    Location: Chanhassen, MN