Senior Regulatory Affairs Manager

Panther Life Sciences • New York, NY

1d

About The Position

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, the director 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%.

Requirements

• 8–12 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
• Practical experience operating under ISO 22716, ISO 13485, and ISO 9001
• Experience reviewing or designing clinical study protocols for medical aesthetic devices

Nice To Haves

• Demonstrated experience navigating combination product risk
• Prior TGA / Australian regulatory experience
• Familiarity with aesthetic device submissions
• 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

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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed