Senior Manager, Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Take charge of the complete lifecycle of FDA premarket applications, focusing initially on the creation and management of 510(k) submissions to achieve clearance. This involves drafting technical documentation, overseeing agency interactions, and collaborating with Operational, Legal, and Clinical teams.

• Implement and uphold compliance across various and overlapping jurisdictions, including FDA (Device, Drug & Compounding) and CMS (CLIA/CAP).

• Act as the primary regulatory contact for federal and state agency audits, inspections, or inquiries related to submissions.

• Develop and enhance the "Technical Playbook" for our medical product operations, ensuring the company remains at the forefront of evolving state, federal, and international regulations.

⛳️ Requirements

• Over 12 years of experience in Regulatory Affairs, particularly within the Medical Device sector and IVDs. Familiarity with pharmacy compounding is advantageous.

• A proven track record with the FDA, having personally drafted multiple successful 510(k) clearances, specifically for IVDs.

• Extensive, practical experience navigating the key areas of health regulation: FDA, DEA, CMS/CLIA, and FTC. International regulatory experience is a plus.

• An advanced degree (Masters in Regulatory Affairs, PhD, or JD) or equivalent professional experience.

• Ability to thrive in fast-paced environments where the product roadmap changes rapidly and demands agile regulatory solutions.

• A proactive self-starter capable of working independently with high-level guidance, skilled at recognizing and addressing regulatory needs without continuous oversight.

🏝️ Benefits

• Competitive salary & equity compensation for full-time positions.

• Unlimited PTO, company holidays, and quarterly mental health days.

• Comprehensive health benefits including medical, dental & vision, along with parental leave.

• Employee Stock Purchase Program (ESPP).

• 401k benefits with employer matching contributions.

• Offsite team retreats.