Job Summary:
Genomics is seeking a Director of Regulatory Affairs who will provide strategic and operational leadership across global regulatory activities for medical products, particularly in the IVD, Software as a Medical Device (SaMD), and AI-driven medical device space. This role focuses on securing timely approvals, maintaining compliance, and guiding cross-functional teams through the product lifecycle.
Key Responsibilities:
- Develop and lead global regulatory strategies from development to post-market.
- Provide expert regulatory advice, assess risks, and propose innovative solutions.
- Monitor and communicate changes in UK, EU, and FDA regulations.
- Manage regulatory submissions and approvals, including ongoing maintenance.
- Lead and grow the Regulatory Affairs and Quality Assurance (RAQA) team.
- Oversee vigilance and regulatory agency communications.
- Align regulatory activities with broader business objectives.
- Clearly communicate complex regulatory topics to various stakeholders.
Ideal Candidate Profile:
- Extensive regulatory experience with IVDs, SaMD, or AI as a medical device.
- Proven success in preparing and submitting regulatory documentation (UK, EU, US).
- Experienced in working with regulatory authorities.
- Strong leadership and team development skills.
- In-depth knowledge of UK, EU, and FDA regulations.
- Excellent strategic, analytical, and communication skills.
- Strong interpersonal skills and stakeholder management.
Bonus Qualifications:
- Recognized thought leader in a relevant field.
- Experience in both large corporations and startups.
- Background in wellness or health promotion.
Job sourced from Genomics.