Vice President, Regulatory Affairs Job at Confidential, Tampa, FL

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  • Confidential
  • Tampa, FL

Job Description

Vice President, Regulatory Affairs

About the Company

Innovative provider of surgical solutions for peripheral nerve injuries

Industry
Biotechnology

Type
Public Company

Founded
2002

Employees
201-500

Categories

  • Biotechnology
  • Medical
  • Medical Device
  • Medical Devices
  • Health Care
  • Health & Wellness
  • Biotech
  • Life Sciences
  • Manufacturing
  • Medical Care
  • In-Vitro
  • Pharmaceuticals
  • Medicine
  • Chemical Products

Specialties

  • medical device
  • peripheral nerve repair
  • biotechnology
  • tissue engineering
  • regenerative medicine
  • translational science
  • processed nerve allograft
  • biologics
  • life science
  • and breast reconstruction nerve repair

About the Role

The Company is seeking a Vice President of Regulatory Affairs to join their Executive Team. The successful candidate will be responsible for the development and execution of domestic and international regulatory strategies in alignment with the company's mission to restore health and improve the quality of life. This includes leading regulatory activities for new product and therapy development, market approval, and ongoing product registrations. The VP, Regulatory Affairs will also be involved in shaping regulatory policy with external groups and must have a proven track record of managing regulatory interactions, including Biologics License Applications and other relevant submissions. The role requires a strategic leader with the ability to cultivate relationships with regulatory agencies and industry groups, as well as a strong background in regulatory affairs within the regenerative medicine, medical device, or pharmaceutical sectors. Candidates for the VP, Regulatory Affairs position at the company should have a Bachelor's degree (Master's or Doctorate preferred) and at least 15 years' of experience in a related field, with a focus on biologics. A minimum of 5 years' in a leadership role with direct reports is essential. The ideal candidate will have a deep understanding of regulatory processes and a history of successful interactions with the FDA and other international regulatory bodies. Key responsibilities include acting as the authorized regulatory representative, managing regulatory strategy, and overseeing a team to ensure compliance with all relevant regulations. The role demands excellent communication, analytical, and organizational skills, as well as the ability to build and maintain strong, collaborative relationships both internally and externally.

Hiring Manager Title
Chief Executive Officer

Travel Percent
Less than 10%

Functions

  • Medical Care/Hospital Administration
Confidential

Job Tags

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