Regulatory Affairs Specialist

3 weeks ago

Hertfordshire, United Kingdom Zest Scientific (division of Zest Business Group) Full time
Position Overview

Location: Hybrid.

Employment Type: Full-time, Permanent

About Zest Scientific:

Zest Scientific, a division of Zest Business Group, is in search of a Regulatory Affairs Specialist with a robust background in Medical Device Regulation. This position is integral to a global drug development organization, focusing on ensuring adherence to regulations across diverse medical device categories, including combination products, drug/device combinations, and in vitro diagnostics (IVDs). We seek a proactive individual eager to enhance their career in a vibrant and challenging setting.

Key Responsibilities:

  • Clinical Trial Applications: Guarantee that regulatory standards for Clinical Trial Applications involving medical devices (both physical and digital, including IVDs) are fulfilled.
  • Regulatory Surveillance: Persistently monitor and evaluate modifications in the UK regulatory landscape, delivering impact analyses and adjusting frameworks as required.
  • Trade Association Engagement: Collaborate with trade associations (e.g., ABHI, ABPI, MedTech) to collect and share regulatory insights.
  • Regulatory Framework Execution: Assist in the implementation and modification of the medical device regulatory framework throughout the UK.
  • Regulatory Guidance: Offer expert regulatory guidance to project teams, aiding in the acquisition and maintenance of UKCA marks and other regulatory milestones.
  • Agency Collaboration: Facilitate communication with the MHRA and engage in external regulatory agency audits to mitigate non-compliance risks.
  • Training and Development: Lead training sessions on medical device regulations and contribute to the professional growth of departmental members.
  • Product Development Support: Provide regulatory expertise during the development of new products and ensure accurate regulatory documentation is maintained.
  • Documentation and Compliance Review: Scrutinize product and process documentation for compliance and ensure timely renewals.
  • Project Coordination: Serve as a liaison between project teams, addressing inquiries and facilitating the flow of information.
  • Impact Analysis: Evaluate the implications of changes to existing products and practices, providing comprehensive assessments.
  • Marketing Compliance Review: Assess marketing materials for regulatory compliance and advise commercial teams on related matters.

Candidate Profile:

  • Educational Qualifications: Possesses a scientific degree.
  • Industry Acumen: Profound understanding of the medical devices sector, with experience in the pharmaceutical industry.
  • Regulatory Proficiency: Extensive knowledge in Medical Device Regulation, particularly concerning combination products, drug/device combinations, and IVDs.
  • Project Management Skills: Demonstrated ability to lead regulatory initiatives and resolve intricate issues.
  • Strategic Insight: Capable of contributing to strategic planning and goal-setting processes.
  • Technical Comprehension: Strong aptitude for understanding scientific and technical information related to company products.

What We Offer:

  • Competitive Compensation: Salary, bonus, and car allowance.
  • Career Development: Opportunities for professional advancement in a stimulating and supportive environment.
  • Collaborative Environment: A team-oriented workplace that values and supports your contributions to regulatory initiatives.
  • Influential Role: A significant opportunity to shape the regulatory landscape for medical devices within a global organization.

Important Note: This position does not provide sponsorship or relocation assistance.

Application Process:

  • If you possess the necessary expertise and are motivated to advance your career, we encourage you to submit your CV and a cover letter outlining your relevant experience and motivation for applying.

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