Medical Device Clinical Safety Specialist
hace 14 horas
Bristol
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., • 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.