Clinical Regulatory Lead

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Job title : Clinical Regulatory Lead - ACTIVE DEVICES

Reports to : Associate Head of Clinical Compliance

Location : Home based in UK, Spain, Germany, Ireland, Netherlands, Italy, France

BSI is unable to provide relocation or visa sponsorship for this vacancy.

We are seeking a Clinical Regulatory Lead specialized in ACTIVE MEDICAL DEVICES to join our Global Regulatory Compliance team. This role involves clinical regulatory support to operational teams and clinicians within BSI, requiring in-depth knowledge of regulatory requirements for active medical devices. The successful candidate will support certification recommendations by demonstrating comprehensive knowledge of clinical regulations, guidance, and standards.

Responsibilities : Provide expertise related to competence and certification.

Monitor competence throughout clinical oversight via internal audits.

Conduct audits of medical devices, maintaining awareness of BSI’s systems, and handle escalated queries.

Support compliance with certification processes and ensure no systematic non-conformities during audits.

Provide leadership and mentoring in medical device expertise for existing and new schemes.

Advise and support Global Heads, Product Specialists, and Scheme Managers.

Assist in developing and delivering training on medical device regulations, updates, and standards.

Candidate Profile : Strong experience and knowledge of regulatory and compliance requirements for active medical devices.

Degree or higher in medicine, nursing, biomedical sciences, biostatistics, or related fields.

Broad clinical and technical understanding of industry products.

Good understanding of Medical Devices Regulations, guidance, and standards.

Understanding of clinical evaluation, data analysis, and clinical study design.

Why Join BSI? BSI helps 80,000 clients worldwide to improve their businesses, from medical devices to space exploration, embedding habits of excellence for better performance, risk management, and sustainable growth. We offer a competitive rewards package, including leave, holidays, development opportunities, and flexible benefits.

Our core behaviors are Client-centric, Agile, and Collaborative, ensuring BSI is a great place to work and succeed.

Diversity & Inclusion : We are committed to workforce diversity and creating a sense of belonging. We support accommodations for disabilities during recruitment.

Interviews may be face-to-face or virtual, based on comfort and circumstances.

Additional Details : Seniority level : Mid-Senior level

Employment type : Full-time

Job functions : Healthcare Provider, Professional Services

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