Clinical Regulatory Lead

BSI; Spalding; Remote; GBP 70,000 - 90,000; Full time

Job summary

A leading global business standards company is seeking a Clinical Regulatory Lead specializing in active medical devices. This home-based role involves providing regulatory support, ensuring compliance, and mentoring in medical device expertise. Candidates must have strong knowledge of regulatory requirements, a related degree, and a solid understanding of clinical evaluation processes.

Benefits

Annual leave

Learning and development opportunities

Flexible benefits

Qualifications

• Strong experience and knowledge of regulatory and compliance requirements for active medical devices.
• A degree or higher in medicine, nursing, biomedical sciences, biostatistics, or a related discipline.
• Good understanding of Medical Devices Regulations, guidance, and standards.

Responsibilities

• Provide input and expertise related to competence and certification.
• Monitor competence throughout the clinical oversight process via internal audits.
• Deliver and support audits of medical devices.

Skills

Regulatory requirements knowledge

Clinical evaluation processes

Leadership and mentoring

Education

Degree in medicine, nursing, biomedical sciences, or related discipline

Job description

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

Further duties include:

• Providing input and expertise related to competence and certification.
• Monitoring competence throughout the clinical oversight process via internal audits.
• Delivering and supporting audits of medical devices to maintain awareness of BSI’s systems and handling escalated queries.
• Supporting processes and procedures to ensure full compliance as a Certification / Notified Body with no systematic non-conformities during audits.
• Providing leadership and mentoring in Medical device expertise for existing and new Global Schemes.
• Offering advice and support to Global Heads, Product Specialists, and Scheme Managers.
• Assisting in developing and delivering internal and external training materials on Medical Devices, ensuring up-to-date knowledge of regulatory changes and amendments.

The successful applicant will have:

• Strong experience and knowledge of regulatory and compliance requirements for active medical devices.
• A degree or higher in medicine, nursing, biomedical sciences, biostatistics, or a related discipline.
• Broad clinical and technical understanding of client industry products.
• A good understanding of Medical Devices Regulations, guidance, and standards.
• Knowledge of clinical evaluation processes, data analysis, and clinical study design.

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Do you believe the world deserves excellence?

As the leading global business standards company, BSI helps 80,000 clients worldwide improve their businesses. From business continuity to recycling waste, from medical devices to space exploration, we enable businesses to embed habits of excellence to perform better, manage risks effectively, and achieve sustainable growth, impacting many lives globally.

As a BSI team member, you will enjoy an extensive, competitive total rewards package, including annual leave, bank holidays, learning & development opportunities, and flexible benefits tailored to your lifestyle.

Our Excellence Behaviours: Client-centric, Agile, Collaborative—these guide how we operate at BSI, ensuring a great workplace and successful business.

D&I Policy

BSI is committed to workforce diversity, reflecting our clients and communities. We aim to foster a sense of belonging by providing opportunities for development, growth, and engagement within our global organization, all while having fun doing great work. BSI is a community where everyone can thrive.

If you require reasonable accommodations during the recruitment process due to a disability or impairment, please inform your Talent Acquisition Partner.

We conduct face-to-face interviews where appropriate and possible. If invited for an in-person interview but prefer a virtual one, please discuss this with our recruitment team.