Director of Regulatory
2 weeks ago
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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