Medical Device Clinical Safety

Medical Device Clinical Safety Specialist – 6-Month Contract | Hybrid or Remote

We are seeking an experienced
Medical Device Clinical Safety Specialist
to provide expert safety leadership across medical device (MD) clinical investigations. This role suits a highly skilled professional with hands-on experience in MD clinical safety, safety documentation, and practical application of ISO standards in clinical research settings.

This is a
6-month contract
, starting
January 2026
, offering hybrid working in
Welwyn Garden City
or remote for the ideal candidate.
Outside IR35.

About the Role

In this role, you will act as the primary safety expert for medical device clinical investigations, ensuring compliance with international standards and supporting safety activities throughout the full lifecycle of MD clinical studies.

You will lead the development of core clinical safety deliverables—including
Clinical Investigation Plans (CIP/Protocols), Investigator's Brochures (IB), and Reference Safety Information (RSI)
—and ensure that safety considerations are embedded throughout the design and execution of clinical investigations.

This role requires strong self-leadership, the ability to work independently, and effective collaboration across
multifunctional and multicultural teams
.

Key Responsibilities

Medical Device Clinical Safety Leadership

• Lead all safety-related activities for medical device clinical investigations.
• Provide expert, strategic safety input into study design, documentation, and execution.

Safety Deliverable Development

Independently develop and refine core MD clinical investigation documents:

• Clinical Investigation Plan (CIP/Protocol)
• Investigator's Brochure (IB)
• Reference Safety Information (RSI)

Standards & Regulatory Application

• Apply
  ISO 14155:2020
  across all phases of clinical investigations, with expert-level understanding.
• Implement medical device
  risk management (ISO 14971)
  and benefit–risk assessment principles.

Cross-Functional Collaboration

• Work alongside global clinical, regulatory, quality, and safety teams to ensure high-quality safety oversight.
• Partner with stakeholders across scientific, clinical, operational, and regulatory functions.

Vigilance, Risk & Compliance

• Provide safety expertise for clinical safety and vigilance activities.
• Support safety assessments for medical devices, combination products, and investigational technologies.

What You Will Bring

We are looking for a professional with strong technical expertise and hands-on experience in medical device clinical investigations.

Essential Requirements

• Significant experience in
  MD clinical safety
  , clinical investigations, and vigilance.
• Proven ability to lead development of safety documentation for clinical investigations (CIP, IB, RSI).
• Demonstrated application of
  ISO 14155:2020
  across all phases of MD investigations.
• Experience in
  benefit–risk assessment
  and MD
  risk management
  using
  ISO 14971
  .
• Strong ability to collaborate across multifunctional and multicultural teams.
• Excellent communicator and team player with strong leadership skills.

Desirable

• Experience with
  drug–device combination products
  .
• Background in
  pharmacovigilance (PV)
  .
• Experience in pharmaceutical, biotech, or medical device organisations.
• Broader understanding of MD regulatory frameworks and industry standards.

Education & Background

• Relevant healthcare, scientific, biomedical, or technical background.
• Clinical safety experience within medical devices and/or combination products.
• Understanding of biomedical and technical aspects of medical devices and applicable regulations.

Who Will Thrive in This Role?

Ideal Candidate

• Brings genuine, hands-on MD clinical investigation experience.
• Has deep expertise in MD safety, vigilance, and risk management.
• Confidently applies ISO 14155 and ISO 14971 in practical settings.
• Able to work independently and lead safety documentation end to end.
• Experience with combination products or PV is an advantage.

Not a Match

• Candidates without MD clinical investigation experience.
• PV-only profiles with no device exposure.
• Post-market-only vigilance backgrounds.
• Applicants unfamiliar with ISO 14155 or ISO 14971.
• Individuals without experience developing CIP/IB/RSI.

Role Details

• Contract:
  6 Months
• Start Date:
  12 January 2026
• Location:
  Welwyn Garden City – hybrid;
• IR35 Status:
  Outside IR35
• Right to Work:
  Full UK Right to Work required