Regulatory Affairs Project Manager

Metabyte • Saint Paul, MN

383d • $91,520 - $99,840

About The Position

The Regulatory Affairs Project Manager at Metabyte, Inc. is responsible for leading project submissions for regulatory approvals, applying advanced regulatory expertise, and guiding cross-functional partners. This role involves developing and implementing regulatory strategies to ensure the timely introduction of new products into domestic and international markets, coordinating the preparation of regulatory submissions, and interfacing with regulatory agencies to facilitate approvals. The position requires a strong understanding of FDA regulations and EU MDR requirements, particularly for Class III implantable medical devices.

Requirements

• Bachelor's degree in medical, science, or engineering related discipline or equivalent experience.
• 8 years of experience in the medical device industry, with 5 years related to FDA and EU MDR submissions for Class III devices.
• Strong written, verbal, presentation, and organizational skills.
• Working knowledge of QSR, ISO, and EN standards.
• Experience reviewing manufacturing operations and changes.

Nice To Haves

• Knowledge of regulatory requirements for Japan, Canada, and other countries.
• Experience with project management in a regulatory context.

Responsibilities

• Lead project submissions for regulatory approvals.
• Identify and resolve regulatory issues independently.
• Develop and implement regulatory strategies for new products.
• Coordinate preparation of regulatory submissions, ensuring they are complete and scientifically sound.
• Interface with regulatory agencies to facilitate timely reviews and approvals.
• File necessary applications and handle government interactions for regulatory processes.
• Provide guidance on regulatory requirements to product development teams.
• Author and submit clinical trial applications and CE mark applications.
• Review and approve engineering and validation study protocols and reports.
• Review and approve manufacturing changes for Class III implantable medical devices.

Benefits

• Health insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree