Regulatory Affairs Manager

What You Can Expect

This role will work hands-on with cross-functional teams to develop and execute regulatory strategies that support business objectives while ensuring full compliance with applicable regulations and standards, including compliance with US FDA regulations governing the distribution and sale of medical devices domestically and internationally. The role also serves as the primary liaison with regulatory authorities, ensuring labeling, marketing materials, and post-market activities meet domestic and international regulatory requirements.

How You'll Create Impact

1. Author, prepare and submit U.S. and global regulatory filings, including Traditional and Special 510(k)s, Letters to File, Pre-Subs, IDEs, technical documentation for European Union, and related submissions.
2. Maintain and update regulatory SOPs and work instructions, ensuring alignment with current regulations, standards and guidance changes.
3. Monitor and manage surveillance of evolving regulations, standards and guidance, and drive implementation required changes impacting product design, safety, regulatory compliance, post-market activities, and QMS processes.
4. Execute regulatory strategy to enable timely development, registration, and commercialization of medical devices across the product lifecycle.
5. Participate and provide regulatory guidance and expertise to cross-functional teams, including R&D, Quality Assurance, and Marketing, throughout the product lifecycle.
6. Assess and interpret regulatory requirements and provide recommendations on product development plans, labeling, human factors studies, and clinical trial designs to ensure compliance.
7. Manage and maintain regulatory documentation, product registrations, and regulatory correspondence while serving as the primary liaison with regulatory authorities including FDA, notified bodies, and other agencies to drive product approvals, clearances, and registrations
8. Establish and maintain Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activities and reports in compliance with global regulatory requirements
9. Ensure compliance of labeling and promotional materials with approved claims and regulatory requirements.
10. Establish and maintain relationships with key stakeholders, industry organizations, and trade associations to stay informed about regulatory changes and best practices.
11. Train and mentor teams on regulatory requirements, procedures, and best practices to strengthen compliance execution.
12. Perform additional regulatory and compliance activities as assigned or at management’s discretion, supporting organizational priorities and ensuring ongoing adherence to global regulations and QMS standards.

What Makes You Stand Out

• In-depth knowledge of medical device regulations and standards, such as FDA regulations (21 CFR Part 820) and ISO 13485
• Working knowledge of IEC 60601 Standards, Human Factors Standards and Labeling Knowledge 15223-1
• Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions
• Experience interacting with regulatory agencies, such as the FDA and notified bodies
• Excellent project management skills, with the ability to prioritize and manage multiple projects simultaneously
• Strong leadership and communication skills, with the ability to collaborate effectively with cross-functional teams and influence key stakeholder
• Experience with product development processes and design controls
• Proficient with Microsoft Office tools (including Word, Excel, PowerPoint)
• Ability to develop and track a variety of diverse project budgets and identify key performance indicators in a fast-paced, changing environment
• Ability to present scientific and technical information in a concise and clear manner

Your Background

• Bachelor's degree in a relevant discipline required
• Minimum of 8 years of regulatory affairs experience in the medical device industry required
• International regulatory experience required
• Regulatory Affairs Certification (RAC) preferred

Physical Requirements

Travel Expectations

Up to 15%

Salary Expectations

$140,000 - $150,000 USD