Director of Regulatory

4 weeks ago


UK, UK, United Kingdom Walker Cole International Full time

Director of Regulatory Affairs


Walker Cole International are delighted to be partnering with a large IVD multinational, who are looking to hire a Director of Regulatory Affairs. This is a fully remote position that requires up to 20% travel. The successful candidate will lead a dynamic team, oversee all regulatory activities, and be responsible for the recruitment and development of new team members.


Responsibilities


  • Lead and manage the regulatory affairs team, providing direction, mentorship, and support.
  • Develop and implement regulatory strategies to ensure compliance with global IVD regulations
  • Oversee the preparation and submission of regulatory documents to health authorities.
  • Monitor and interpret regulatory requirements and trends to ensure the company's products meet all regulatory standards.
  • Collaborate with cross-functional teams, including R&D, Quality Assurance, and Clinical Affairs, to support product development and regulatory submissions.
  • Represent the company in interactions with regulatory agencies and external stakeholders.
  • Recruit, train, and develop new regulatory affairs team members to support the company’s growth and compliance objectives.



Required Experience


  • Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field (Advanced degree preferred).
  • Minimum of 10 years of regulatory affairs experience within the IVD or medical device industry.
  • Proven leadership experience with a track record of managing and developing high-performing teams.
  • In-depth knowledge of global IVD regulations, including FDA, CE, and other relevant regulatory bodies
  • Excellent project management, organizational, and communication skills.
  • Ability to travel up to 20% of the time for regulatory meetings, conferences, and team management.



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