Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager

Panther Life Sciences is seeking a senior regulatory affairs manager to shape the future of its regulatory strategy across an ambitious portfolio spanning cosmetics, medical devices, and therapeutics. This is a high-impact leadership role at the intersection of science, strategy, and innovation, managing one of Panther's most critical areas of investment while architecting the regulatory roadmap that will bring transformative, shelf-stable, patient-centric treatments to market.

This role is central to Panther's success. The direction will architect the regulatory frameworks required to bring transformative, shelf-stable, patient-centric treatments to global markets, spanning cosmetics, medical devices, and therapeutics. As a key member of the leadership team, you will drive U.S. FDA and international submissions, every stage of product development from concept to global launch. This individual brings a rare combination of ambition, humility, precision, and deep collaboration, paired with a passion for next-generation medical products and improving the patient experience. The right leader will help unlock Panther's full potential.

Some travel may be required approximately 10%.

Responsibilities

• Define and execute regulatory pathways for devices, therapeutics, cosmetics, and platform submissions.
• Lead FDA filings (including RFD and IND pathways) and guide parallel global filings.
• Ensure tight integration between regulatory strategy, R&D, clinical, and commercial teams.

• Lead medical device approval for Panther's device(s), including at least one parallel global agency.
• Lead clinical trial preparation and documentation
• Support quality initiatives in accordance with ISO 9001

Qualifications

• 6–12+ years of medical device regulatory experience, with at least 3 years in a lead role at a company developing a novel, non-predicate device
• Direct experience navigating novel device classification pathways with FDA CDRH (De Novo, PMA), including preparation of classification arguments and special controls frameworks
• Working knowledge of 21 CFR 878 and familiarity with CDRH reviewers in the aesthetic/dermatology device space
• Proven ability to independently own Pre-Submission (Q-Sub) meetings with FDA
• Experience operating under quality system (e.g. ISO 13485, and ISO 9001)
• Experience reviewing or designing clinical study protocols for medical devices

Preferred Qualifications

• Prior experience with clinical trials outside the US
• Familiarity with aesthetic device submissions
• Demonstrated experience navigating FDA device designations
• Background at an early-stage or Series A/B device company where regulatory strategy is built from the ground up
• Understanding of how novel device classification intersects with IP strategy
• Working knowledge of the MoCRA framework
• Experience working on Software as a Medical Device (SaMD)

Benefits

• Equity in the form of Stock Options
• Robust Health Insurance includes Medical, Dental, Vision
• Life, AD&D, and Short-Term Disability Insurance
• In-person company events
• Fully-stock kitchen
• In-office lunch twice a week
• Working with a world-class team in technology and healthcare on the most innovative solutions
• Paid time off and Paid Company Holidays.

Panther Life Sciences is an equal opportunity employer committed to building a diverse and inclusive workplace. We welcome applicants from all backgrounds and do not discriminate based on race, color, religion, gender, gender identity or expression, sexual orientation, pregnancy, marital or partnership status, age, national origin, citizenship, veteran or military status, disability, medical condition, genetic information, caregiver status, or any other characteristic protected by law.