Medical Device Clinical Safety Specialist

Medical Device Clinical Safety Specialist (Contract – 6 Months)

Start Date:
January 2026

Location:
Welwyn Garden City (Hybrid)

IR35:
Outside

Right to Work:
Full UK RTW required, no sponsorship

Role Summary

An experienced
Medical Device Clinical Safety Specialist
is required to provide expert support across all safety-related activities for medical devices, with a strong focus on
clinical investigations
. This role is ideal for a candidate with deep, hands-on experience in
MD clinical safety, vigilance, ISO 14155, risk management (ISO 14971)
, and the development of core clinical investigation documents.

You will work cross-functionally within multicultural teams and operate with a high level of independence, providing strategic and operational safety leadership throughout the lifecycle of
medical device clinical investigations
.

Key Responsibilities

• Lead and deliver
  safety strategy and safety input
  for medical device clinical investigations.
• Develop, author, and provide expert safety contributions to:
• Clinical Investigation Plan (CIP/Protocol)
• Investigator's Brochure (IB)
• Reference Safety Information (RSI)
• Ensure robust application of
  ISO 14155:2020
  across all stages of clinical investigations.
• Support safety review processes, safety governance activities, and cross-functional risk assessments.
• Provide
  medical device safety expertise
  across investigations, benefit-risk evaluations, and device risk management activities.
• Partner effectively with global teams, clinical operations, regulatory, quality, and risk management.
• Contribute to safety oversight for
  combination products
  where applicable.
• Apply strong self-leadership and operate autonomously in a fast-paced environment.

Essential Requirements

• Significant hands-on experience in
  medical device clinical investigations
  .
• Proven background in
  medical device clinical safety
  and
  vigilance
  .
• Practical, demonstrable application of
  ISO 14155
  in real-world clinical investigation settings.
• Experience contributing to and independently leading the development of
  CIP, IB, RSI
  and other MD safety deliverables.
• Strong working knowledge of
  ISO 14971
  and medical device
  benefit–risk assessment
  .
• Ability to collaborate effectively with
  multifunctional and multicultural teams
  .
• Excellent communication, leadership, and documentation skills.
• Relevant
  healthcare, scientific, or biomedical background
  with understanding of medical device technologies, regulations, and clinical safety principles.

Desirable Experience

• Experience with
  drug–device combination products
  .
• Background in
  drug safety (pharmacovigilance)
  .
• Prior experience in
  pharmaceutical, biotechnology, or medical device companies
  .
• Broader understanding of
  medical device regulatory frameworks
  and global industry standards.

Ideal Candidate Profile

We want someone who:

• Has genuine, demonstrable experience in
  medical device clinical investigations
  .
• Brings strong expertise in
  MD safety, vigilance, and risk management
  .
• Confidently applies
  ISO 14155
  and
  ISO 14971
  to real-world clinical studies.
• Can independently lead and deliver high-quality MD safety documentation.
• Has experience with
  combination products
  or PV as an added strength.

We do
not
want:

• Pure drug safety or PV-only profiles with no MD exposure.
• Candidates without clinical investigation experience.
• Individuals with only post-market vigilance backgrounds.
• Applicants lacking MD benefit–risk assessment or practical ISO 14155/14971 experience.
• Anyone without hands-on involvement in CIP/IB/RSI development.

Medical Device Clinical Safety, MD Clinical Investigations, ISO 14155, ISO 14971, Clinical Investigation Plan, Investigator's Brochure, Reference Safety Information, Medical Device Vigilance, Benefit-Risk Assessment, Combination Products, Medical Device Risk Management, Clinical Safety Lead, Clinical Safety Specialist, Device Safety Oversight, Medical Device Regulations.