Regulatory Affairs Specialist

Located in Chanhassen, Minnesota, PMT Corporation was established in 1979 as a private company dedicated to the research and development of specialty products, devices and instruments used in the medical field. PMT Corporation is known for manufacturing and distributing high end, innovative products within the orthopedic, neurosurgery and plastic surgery markets. PMT Corporation provides future opportunities in sales, marketing and management.

POSITION

The Quality and Regulatory Department support the registration and compliance of PMT’s products in the US and for over 100 distributors worldwide, selling specific PMT products. The Regulatory Affairs Specialist will focus on assisting PMT maintain product compliance with FDA/MDSAP, ISO, and MDD/MDR requirements. This is a salary position and is an in-office position where the candidate will be working at PMT headquarters in Chanhassen, MN 8:00am – 4:30pm, M-F.

DUTIES

• Assess regulatory requirements and 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 relating to design, engineering, or manufacturing.
• Work directly with internal auditors and quality managers on compliance related matters.
• Maintain good relationship 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 US and international submissions for new products or products with changes in a timely manner.

REQUIREMENTS

• Bachelor’s degree in science, Regulatory Affairs, engineering, or other related field.
• Strong attention to detail.
• Minimum 2 years’ 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 US and EU, experience in other countries a plus.
• Strong work ethic able to consistently exceed expectations.
• Excellent communication and time management skills.
• Proficient in Microsoft Office Suite and Adobe.

PMT is an Equal Opportunity Employment