Senior Specialist- Regulatory Affairs

Health Innovation Research Alliance Northern Ireland; Belfast; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading healthcare research organization in Belfast seeks an experienced Regulatory Expert to ensure compliance solutions for client companies in IVD/CDx development. The ideal candidate must have over 10 years in regulatory roles, with expertise in regulatory submissions and a strong understanding of EU and US regulations. Responsibilities include preparing regulatory documents, supporting project teams, and conducting gap analyses. This role emphasizes adherence to quality and regulatory standards while promoting company culture.

Qualifications

• 10+ years relevant industry experience in regulatory roles.
• Over 5 years’ experience in a medical device/IVD environment.
• Knowledge of EU and US regulations and IVD/CDx processes.

Responsibilities

• Support project teams with regulatory expertise.
• Research and prepare regulatory submission documents.
• Manage IVD performance studies and clinical investigations.
• Conduct gap analyses and prepare technical reports.

Skills

Regulatory expertise

Clinical investigations

IVD/CDx development

Technical documentation

Global regulatory strategies

Education

Engineering or Scientific honours degree

Job description

To be an integral member and significant contributor to project team(s) in the development and delivery of global compliance solutions to client companies, ensuring that client objectives are met and exceeded at all times. This will require the utilisation of a platinum standard approach to regulatory research, internal and external stakeholder satisfaction as well as an innate work ethic and attention to detail that is aligned with the company’s core values.

Key Responsibilities:

• Support the work of the company and project teams in providing specialised regulatory expertise to client companies, ensuring internal procedures and client expectations are met.
• Bring extensive experience in IVD/CDx development, validation, and approval to client organisations, offering expert strategies and guidance.
• Research and prepare regulatory submission documents, including IVDR Annex XIV applications, CTA’s, study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files, Design Dossiers, PMDA Briefing Documents, and Submissions.
• Assist in understanding regulatory requirements for investigational devices, managing IVD performance studies/clinical investigations worldwide (e.g., IVDR and 21 CFR 812).
• Maintain up-to-date information on global regulatory requirements for IVD devices and manage the company's web-based clinical trial planning tool.
• Conduct gap analyses for clients and prepare reports such as technical documentation and design history files.
• Contribute to global guidance documents and white papers.
• Prepare regulatory documents like Performance Evaluation Plans/Reports and Investigator Brochures on behalf of clients.
• Leverage professional networking to promote the company and its services.
• Design and deliver client presentations, including training and solutions proposals, at industry events.
• Engage in ongoing professional development to stay current with quality and regulatory standards.
• Participate in company culture initiatives to foster a positive work environment.
• Perform additional duties as assigned by management.

Qualifications:

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