The Opportunity

The Regulatory Affairs Manager will lead regulatory strategies and submissions for Class III medical devices to the FDA, ensuring timely approvals and compliance throughout the product lifecycle. Reporting directly to the Vice President of Regulatory Affairs, this role involves close collaboration with cross-functional teams including R&D, Quality Assurance, Clinical Affairs, Manufacturing, and Marketing. The ideal candidate is a strategic thinker with deep expertise in FDA regulations for high-risk diagnostic devices, capable of navigating complex submission processes while driving organizational goals.

How You'll Contribute

· Develop and execute regulatory strategies for Class III device submissions, including Premarket Approval (PMA) applications, supplements, and amendments, ensuring alignment with FDA requirements and company objectives.

· As needed, lead the preparation, review, and submission of regulatory documents, such as Investigational Device Exemptions (IDEs), 510(k)s (as applicable for related products), and post-market surveillance reports.

· Serve as the primary liaison with the FDA, managing communications, responding to agency inquiries, and facilitating meetings or audits.

· Collaborate cross-functionally with R&D, Clinical Operations, Quality, and Operations teams to integrate regulatory considerations into product development, design controls, risk management, and validation processes.

· Conduct regulatory assessments for new product concepts, modifications, and international expansions, providing guidance on compliance with 21 CFR Parts 803, 806, 820, and other relevant regulations.

· Oversee the maintenance of regulatory files, tracking systems, and documentation to support audits, inspections, and ongoing compliance in collaboration with quality teams.

· Monitor evolving FDA policies, guidance documents, and industry trends in diagnostics, advising senior leadership on potential impacts and opportunities.

· Support VP on due diligence for partnerships, acquisitions, or licensing agreements involving regulatory aspects.

What You'll Bring

· Bachelor’s degree in Life Sciences, Engineering, or a related field; advanced degree (Master’s or PhD) preferred.

· Minimum of 8 years of experience in regulatory affairs within the medical device industry, with at least 3-5 years focused on Class II-III devices and FDA submissions.

· In-depth knowledge of FDA regulations, ISO 13485, and Quality System Regulations (QSR) for medical devices.

· Strong understanding of clinical trial design, biostatistics, and risk management (e.g., ISO 14971) as they relate to regulatory submissions.

· Excellent written and verbal communication skills, with the ability to convey complex regulatory information to diverse stakeholders.

· Proven ability to work cross-functionally in a fast-paced environment, balancing strategic planning with tactical execution.

· Proficiency in regulatory software tools (e.g., submission management systems) and Microsoft Office Suite.

· Ability to travel up to 20% for FDA meetings, conferences, or site visits.

· Desired: Prior leadership experience in a managerial role, with demonstrated ability to manage projects and teams.

· Desired: Certification such as RAC (Regulatory Affairs Certification).

· Desired: Proven track record of successful PMA submissions for diagnostic devices, including experience with in vitro diagnostics (IVDs) or companion diagnostics.

What We'll Offer

· 22 days of PTO with the possibility to carry over 10 days to the following year.

· Company Holidays, plus your Birthday off!

· Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).

· Flexible work schedule