Director of Regulatory Affairs - Medical Devices

Posted 22 January 2024
Salary Negotiable
Job type Full Time
Discipline CRO & Clinical OperationsMedical Devices
Contact NameNuria Benito

Job description

​Mantell Associates is partnered with a rapidly growing Medical Device CRO, who is looking to expand their team with the addition of a Director of Regulatory Affairs.

Director of Regulatory Affairs - Responsibilities:

  • Develop and implement effective Regulatory strategies by maintaining Policy and Intelligence

  • Mentor a team of regulatory professionals, providing guidance and leadership to ensure adherence to global regulations and internal policies

  • Be at the forefront of new and developing regulations and guidelines

  • Collaborate with cross-functional teams, including clinical development, medical affairs, and quality assurance, to ensure regulatory compliance and timely product approval

  • Provide an overview of RA Policy to stakeholders and staff

  • Monitor and interpret changes in global regulations and communicate the impact on the company's products and operations

  • Ensure submission publishing is well executed and on time

  • Engage relevant staff to support M&A activities

  • Manage a Regulatory Affairs network externally and internally

  • Recruit and manage a team

Director of Regulatory Affairs - Requirements:

  • Bachelor's or advanced degree in a scientific or medical field

  • Leadership, communication, high value reliable

  • Medical doctor, regulatory agency, exert for medical device or IVD

  • Strong experience within Regulatory Affairs in the Biotech / Pharmaceutical space, including leadership experience

  • Thorough understanding of global regulations (FDA, EMA, ICH) and their impact on product development and approval

  • Strong leadership and management skills, with the ability to mentor and develop a team of regulatory professionals

  • Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders

  • Proven track record of Global Regulatory Processes

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.