Clinical Regulatory Lead

畅敲潭整; United Kingdom; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading global business standards company is seeking a Clinical Regulatory Lead specializing in active medical devices. The successful applicant will support regulatory compliance and guidance, ensuring adherence to certification standards. This role offers a rewarding package with diverse team dynamics, emphasizing excellence and continuous development.

Benefits

Annual leave

Bank holidays

Learning & development opportunities

Flexible benefits tailored to lifestyle

Qualifications

• Strong experience with active medical devices regulations.
• Broad technical understanding of client industry products.
• Knowledge of clinical evaluation processes and study design.

Responsibilities

• Provide expertise related to competence and certification.
• Monitor clinical oversight process via internal audits.
• Deliver audits to maintain compliance with standards.

Skills

Regulatory knowledge

Compliance expertise

Data analysis

Education

Degree in medicine, nursing, biomedical sciences or related discipline

Job description

Great that you’re thinking about a career with BSI!

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 of BSI, requiring in-depth experience and knowledge of regulatory requirements for active medical devices. The successful applicant will support certificate recommendations by providing strong, comprehensive knowledge of clinical regulations, guidance, and standards.

Further duties:

• 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 to maintain awareness of BSI’s systems, and handle escalated queries.
• Support processes and procedures to ensure full compliance with Certification / Notified Body standards, with no systematic non-conformities at audits.
• Provide leadership and mentoring in medical device expertise for existing and new Global Schemes.
• Offer advice and support to Global Heads, Product Specialists, and Scheme Managers.
• Assist 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?

At BSI, the leading global business standards company, we help 80,000 clients worldwide improve their businesses. From business continuity to space exploration, we embed habits of excellence to enhance performance, risk management, and sustainable growth, touching lives globally.

As a team member at BSI, you will enjoy a comprehensive 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 define how we operate at BSI, ensuring a great workplace and business success.

D&I Policy:

BSI is committed to workforce diversity, reflecting our clients and communities. We aim to foster a sense of belonging by providing growth opportunities in our global organization, creating a community where everyone can thrive.

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

We are conducting face-to-face interviews where appropriate. If invited but more comfortable virtually, please discuss options with our recruitment team.

Tagged as: 5+ Years