Regulatory Expert

2 months ago


Hertfordshire UK, Eastern England, United Kingdom Zest Scientific Full time

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.

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