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 will focus on clinical regulatory support to operational teams and internal clinicians, requiring in-depth experience and knowledge of regulatory requirements for active medical devices. The successful applicant will support certification recommendations by providing comprehensive knowledge of clinical aspects of regulations, relevant guidance, and standards.

Responsibilities include :

• Providing expertise related to competence and certification.
• Monitoring competence throughout the clinical oversight process through internal audits.
• Delivering and supporting audits of medical devices to ensure compliance and address escalated queries.
• Supporting processes and procedures to maintain full compliance as a Certification / Notified Body with no systematic non-conformities.
• Providing leadership and mentoring in Medical device expertise for existing and new Global Schemes.
• Advising and supporting Global Heads, Product Specialists, and Scheme Managers.
• Supporting the development and delivery of internal and external training on Medical Devices, ensuring up-to-date knowledge of regulatory changes.

Ideal candidate will have :

Join us if you believe the world deserves excellence!

BSI helps 80,000 clients worldwide improve their businesses, from medical devices to space exploration. We embed habits of excellence to help organizations perform better, manage risks, and achieve sustainable growth, impacting lives globally.

We offer an extensive, competitive total rewards package, including annual leave, holidays, learning & development opportunities, and flexible benefits tailored to your lifestyle.

Our core behaviors are : Client-centric, Agile, Collaborative, which guide our work environment and success.

D&I Policy :

We are committed to workforce diversity and creating a sense of belonging for all employees, providing opportunities for growth and engagement in our global community. We welcome reasonable accommodations for applicants with disabilities or impairments during the recruitment process.

Interviews may be conducted face-to-face or virtually, depending on comfort and circumstances.

Job details :

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