Medical Device Clinical Safety Specialist in England

Job description

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.

Extra information

Status

Closed

Education Level

Secondary School

Location

England

Type of Contract

Casual / Part Time Jobs

Profession type

Health / Medical

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English