Regulatory Affairs Manager

About the Role

Are you ready to make a significant impact in the world of medical devices? Join the dynamic team as a Regulatory Affairs Manager, where you will be at the forefront of ensuring our products meet stringent regulatory standards for FDA and Health Canada compliance. This is an exciting opportunity to lead a talented team in managing the regulatory affairs functions, driving timely approvals, and supporting product development across the global landscape.

Key Responsibilities

• Lead Regulatory Submissions: Spearhead the regulatory submission process, ensuring all filings, including 510(k) submissions, PMA applications, RFDs, and international registrations, are executed efficiently and meet all FDA and Health Canada requirements.
• Regulatory Strategy & Compliance: Be the go-to expert for navigating complex regulations, offering proactive guidance to cross-functional teams on regulatory requirements for product realization, marketing authorization, and labeling changes.
• Cross-Functional Collaboration: Work closely with Product Development, Marketing, and other departments to gather critical technical data and ensure alignment with federal regulations across all materials—websites, print, and events.
• Champion UDI Compliance: Oversee the management and submission of Unique Device Identifiers (UDI) to ensure all regulatory standards are met.
• Lead by Example: Guide a team through FDA and regulatory inspections, reviewing design changes, and formulating strategies to stay ahead of any challenges.
• Stay Ahead of Industry Standards: Maintain expert knowledge of FDA 21 CFR 1271, 21 CFR 820, ISO standards, cGMP/CGTP, and other key regulations, ensuring the company is always in compliance.

What You’ll Bring to the Table

• Proven Expertise: At least 5 years of regulatory or quality experience in the medical device industry (or a related field), with strong knowledge of FDA regulations and regulatory submissions.
• Leadership Skills: A natural leader who thrives in a collaborative environment, with the ability to manage and mentor teams while keeping cross-departmental communication flowing smoothly.
• Detail-Oriented & Organized: With excellent attention to detail and exceptional organizational skills, you can balance multiple tasks and ensure high-quality submissions on time.
• Strong Communicator: You’ll be sharing complex regulatory concepts and strategies with clarity and confidence to stakeholders at all levels.

Qualifications

• A Bachelor’s degree in a biological science or related field is required (Master’s preferred).
• At least 5 years of progressive regulatory experience in a regulated medical device environment.
• Ability to lead initiatives and collaborate across departments to ensure successful regulatory outcomes.

What’s in it for You?

• Opportunity to work in a fast-paced, innovative environment where your contributions directly impact the success of groundbreaking medical devices.
• Be part of a passionate team committed to ensuring regulatory compliance and quality in the products that help improve patient lives.
• A dynamic role with leadership responsibilities and room for growth within a global organization.

If you’re ready to take the lead in ensuring the highest standards of regulatory excellence, we want to hear from you!