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.

Due to internal progression, we are looking for a Clinical Regulatory Lead with a specialization in ACTIVE MEDICAL DEVICES to join our Global Regulatory Compliance team. This role focuses on clinical regulatory support to operational teams and internal clinicians of BSI, requiring in-depth experience and knowledge of regulatory requirements for active medical devices. The successful candidate will support certification recommendations by providing comprehensive knowledge of clinical aspects of regulations, guidance, and standards.

Further Duties

• Provide expertise related to competence and certification.
• Monitor competence throughout the clinical oversight process via internal audits.
• Conduct audits of medical devices to maintain awareness of BSI’s systems and handle escalated queries.
• Support processes and procedures to ensure full compliance as a Certification / Notified Body with no systematic non-conformities.
• Provide leadership and mentoring in Medical device expertise for existing and new Global Schemes.
• Advise and support Global Heads, Product Specialists, and Scheme Managers.
• Assist in developing and delivering internal and external training on Medical Devices, ensuring up-to-date knowledge of regulatory changes.

The Successful Applicant Will Have

About BSI

BSI helps 80,000 clients worldwide to improve their businesses, touching lives globally through standards that promote excellence, risk management, and sustainable growth.

Our benefits include competitive rewards, annual leave, holidays, development opportunities, and flexible benefits tailored to your lifestyle.

Our Values

Diversity & Inclusion

BSI is committed to workforce diversity and creating an inclusive environment where everyone can thrive. We provide accommodations for disabilities during our recruitment process.

Interview Process

We conduct face-to-face interviews where possible. If preferred, virtual interviews are available upon request.

Additional Information

Senior level, full-time role in Health Care Provider and Professional Services industries. Referrals can double your chances of an interview.

Location : Various locations in Spain and other countries, with recent postings listed.

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