Regulatory Affairs Project Manager

As the Regulatory Affairs Project Manager, you will lead the planning, execution, and oversight of complex global regulatory submissions and ensure the rigorous maintenance of our Medical Device Quality Management System (QMS). This critical leadership role directly supports rapid portfolio growth, focusing on medical device and Rx drug innovation to meet the company’s 2030 objectives.

What You Will Do

Regulatory Submission Leadership: Leads cross-functional projects to prepare, review, and deliver complex regulatory submissions (e.g., 510Ks, NDAs, ANDAs, NDS) to the FDA and Health Canada on time. QMS and GMP Compliance: Coordinates critical Quality Management System projects, ensuring all system implementations and process improvements align strictly with ISO 13485, ISO 14971, and FDA 21 CFR Part 820 requirements.

Why It Might Be a Fit

This position offers an exciting opportunity to spearhead high-impact projects that shape the future of our professional clinical portfolio. You will safeguard compliance while accelerating commercialization timelines for North America.

Requirements

• Bachelor’s degree in Quality Management, Life Sciences, Regulatory Affairs, or a related technical field.
• At least seven years of experience in regulatory affairs, or a related compliance role within the medical device or pharmaceutical industry, with at least 2 years of project management experience.
• In-depth technical knowledge of medical device GMP standards, specifically ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
• Direct professional proficiency using electronic Quality Management Systems (eQMS), document management systems (DMS), and advanced Project Management software such as Smartsheet.
• Proven track record of leading cross-functional teams and communicating complex technical regulatory info clearly to diverse stakeholders.

Benefits

• medical
• dental
• vision
• basic life insurance
• paid parental leave
• disability coverage
• 401(k) retirement plan with company matching contributions
• 15 vacation/PTO days
• 13 paid holidays
• paid sick leave