Clinical Regulatory Lead

The British Standards Institution (BSI); United Kingdom; Remote; GBP 50,000 - 75,000; Full time

Job summary

A leading global business standards institution seeks a Clinical Regulatory Lead specializing in active medical devices. This role requires strong expertise in regulatory compliance to assist operational teams and internal clinicians. Responsibilities include auditing, mentoring, and developing training materials, supporting the company's commitment to excellence in the medical devices sector.

Benefits

Extensive annual leave

Learning & development opportunities

Flexible benefits tailored to lifestyle

Qualifications

• Strong experience with active medical devices regulation.
• Degree or higher in a relevant discipline.
• Broad clinical and technical understanding of client industry products.

Responsibilities

• Provide regulatory expertise related to competence and certification.
• Support audits and maintain compliance with standards.
• Deliver internal training materials on regulatory changes.

Skills

Regulatory knowledge

Clinical evaluation

Data analysis

Clinical study design

Education

Degree in medicine

Degree in nursing

Degree in biomedical sciences

Degree in biostatistics

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 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 specialism in ACTIVE MEDICAL DEVICES to join our Global Regulatory Compliance team; This role will be focused around clinical regulatory support to the operational teams and internal clinicians of BSI, and requires an in depth experience and knowledge of regulatory requirements of active medical devices. The successful applicant will support certificate recommendations by providing strong comprehensive working knowledge of the clinical aspects of the regulations, relevant guidance and appropriate standards.

Further duties:

• Provide input and expertise related to competence and certification.
• Monitoring of competence throughout the clinical oversight process by internal auditing.
• Deliver and Support the delivery of audits of medical devices to maintain awareness of BSI's systems, and deal with escalated queries.
• Support process & procedures to be a fully compliant Certification / Notified Body with no systematic non-conformities at audit.
• Provide Medical device expertise leadership and mentoring for existing and new Global Schemes.
• Provide advice and support to Global Heads, Product Specialists and Scheme Managers.
• Support the work of the broader team & training lead in developing and delivering Medical Devices' internal & external training materials, ensuring up to date and accurate knowledge of regulatory changes & amendments.

The successful applicant will have:

• Strong experience and knowledge of the regulatory and compliance requirements of active medical devices
• A degree or higher degree in medicine, nursing, biomedical sciences, biostatistics or related discipline
• Broad clinical and technical understanding of client industry products
• A good understanding of Medical Devices Regulations and related guidance and standards
• Understanding of clinical evaluation processes, data analysis, 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 to improve their businesses. From business continuity to recycling waste, from medical devices to the exploration of space, we help businesses embed the habits of excellence so that they perform better, manage their risks more effectively and achieve sustainable growth and in doing so we touch the lives of many across the globe.

As a team member at BSI, you will enjoy an extensive, competitive total rewards package. This includes annual leave, bank holidays, learning & development opportunities, and a wide range of flexible benefits that you can tailer to suit your lifestyle.

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

D&I Policy

BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization all while having fun doing great work. BSI is a community where everyone can thrive.

If you require any reasonable accommodations to be made on account of a disability or impairment throughout out our recruiting process, please inform your Talent Acquisition Partner.

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.