Regulatory Affairs Specialist

3 weeks ago

Belfast, United Kingdom ARC Regulatory Ltd Full time
Job Description

Job Title: Senior Specialist- Regulatory Affairs

Company: ARC Regulatory Ltd

Location: Belfast

About Us: ARC Regulatory Ltd is a Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector.

Job Summary: We are seeking a highly experienced Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring that client objectives are met and exceeded at all times.

Key Responsibilities:

  • Utilise a platinum standard approach to regulatory research, internal and external stakeholder satisfaction, and an innate work ethic and attention to detail that is aligned with the company's core values.
  • Support the work of the company and project teams in the provision of specialised regulatory expertise to client companies, ensuring that internal procedures and client expectations and interests are met.
  • Bring considerable experience in IVD/CDx development, validation, and approval to client organisations, providing expert strategies and guidance to their development programmes.
  • Research and prepare elements of regulatory submission documents on behalf of client companies, including IVDR Annex XIV applications, CTAs, study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files, and Design Dossiers.
  • Assist wider team in understanding the regulatory requirements for an investigational device in the set-up, management, and conduct of IVD performance studies/clinical investigations worldwide.
  • Manage and keep up to date information relating to global regulatory requirements for IVD devices and maintain the company's web-based clinical trial planning tool.
  • Conduct gap analyses on behalf of client companies and prepare associated reports.
  • Contribute to the preparation of global guidance documents and white papers.
  • Contribute to the preparation of other regulatory documents on behalf of client companies.
  • As required, take advantage of professional networking opportunities to promote the company and its services to appropriate parties.
  • Design and deliver formal client presentations, including proposed solutions and client training.
  • Prepare and deliver presentation(s) relevant to the company's regulatory support offerings at industry meetings and conferences.
  • Undertake continuing professional development activity to ensure awareness of current quality and regulatory standards.
  • Contribute to ARC company culture initiatives to maintain a positive and engaging workforce.

Requirements:

  • Engineering or Scientific honours degree or equivalent (10+ years) relevant industry experience.
  • 5+ years experience of working in a medical device/IVD manufacturing or regulatory environment.
  • Experience with IVD/CDx design and development, from feasibility to approval.
  • Knowledge of regulations in key global markets as they pertain to IVD and/or CDx devices (e.g. EU/US).
  • Experience of leading global regulatory submissions (e.g. EU/FDA).
  • Experience developing and maintaining technical documentation (IVDD/IVDR) or design history file documentation (FDA).
  • Experience developing global regulatory strategies for IVD devices.

Skills: Regulatory Affairs, IVDR, CDx

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