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.

Requirements

• 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
• Direct experience navigating novel device classification pathways with FDA CDRH (De Novo, PMA), including preparation of classification arguments and special controls frameworks
• Proven ability to independently own Pre-Submission (Q-Sub) meetings with FDA

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.