Regulatory Affairs Specialist

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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 youre ready to be a part of a collaborative ideadriven 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 Corporations 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 onsite 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:

• Bachelors 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 preemployment Background and Drug Screening

PMT is an Equal Opportunity Employment

Location:Chanhassen MN

JOB CODE: RASJan2025