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Regulatory Expert
3 months ago
Location: Hybrid (Hertfordshire).
Type: Full-time, Permanent
About Us:
Zest Scientific is actively seeking an expert within Regulatory Affairs with extensive experience in Medical Device Regulation to join a global drug development organisation. This role focuses on ensuring compliance across various medical device categories, including combination products, drug/device combinations, and in vitro diagnostics (IVDs). We are looking for a motivated individual ready to advance their career in a dynamic and challenging environment.
Key Responsibilities:
- Clinical Trial Applications: Ensure regulatory requirements for Clinical Trial Applications involving medical devices (physical devices, digital devices, IVDs) are met.
- Regulatory Monitoring: Continuously track and assess changes in the UK regulatory environment, providing impact assessments and adapting frameworks as necessary.
- Trade Association Participation: Engage with trade associations (e.g., ABHI, ABPI, MedTech) to gather and disseminate regulatory intelligence.
- Regulatory Framework Implementation: Support the implementation and adaptation of the medical device regulatory framework across the UK.
- Regulatory Advice: Provide expert regulatory advice to project teams, helping to obtain and maintain UKCA marks and other regulatory milestones.
- Agency Interaction: Facilitate interactions with the MHRA and participate in external regulatory agency audits to minimize non-compliance risks.
- Training and Development: Conduct training sessions on medical device regulations and contribute to the development of departmental members.
- Product Development: Offer regulatory expertise in the development of new products and maintain accurate regulatory documentation.
- Documentation and Compliance: Review product and process documentation for compliance and ensure timely renewals.
- Project Liaison: Act as a liaison between project teams, addressing queries and facilitating information flow.
- Impact Assessment: Assess the impact of changes to existing products and practices, providing detailed assessments.
- Marketing Review: Review marketing materials for compliance and advise commercial teams on regulatory matters.
Candidate Profile:
- Educational Background: Holds a scientific degree.
- Industry Knowledge: Deep understanding of the medical devices industry, with experience in the pharmaceutical sector.
- Regulatory Expertise: Extensive experience in Medical Device Regulation, particularly with combination products, drug/device combinations, and IVDs.
- Project Leadership: Proven ability to lead regulatory projects and resolve complex issues.
- Strategic Contribution: Capable of contributing to strategic planning and goal-setting.
- Technical Understanding: Strong ability to comprehend scientific and technical information related to company products.
What Our Client Offers:
- Competitive Package: Saalry, bonus and car allowance.
- Career Advancement: Opportunities for professional growth in a stimulating and supportive environment.
- Collaborative Culture: A team-oriented workplace that values and supports your contributions to regulatory projects.
- Influence: A significant role in shaping the regulatory landscape for medical devices within a global organisation.
Important Note: This role does not offer sponsorship or relocation support.
Application Process:
- If you possess the required expertise and are eager to advance your career, we invite you to submit your CV and a cover letter detailing your relevant experience and your motivation for applying.
