Role: Medical Device Clinical Safety Specialist
Location: Welwyn with Hybrid working (Or remote for the right candidate )
Hours: Full-time
Pay: £33.58 per hour PAYE basic (excluding holiday pay) or £45.00 per hour (UMB/LTD)
12 Month Contract (Outside IR35)
An excellent opportunity has arisen for a Medical Device Clinical Safety Specialist to join one of our longstanding clients, a leading organisation in the pharmaceutical and life sciences sector. This role offers hybrid working with the option for remote work for the right individual.
Benefits:
* Weekly competitive pay
* Hybrid working / possibility of remote
* Generous holiday leave
* Opportunity to work with a global team on cutting-edge combination products
* Exposure to a wide range of safety, regulatory, and risk management activities
The Requirements:
* Experience supporting or leading medical device clinical investigations
* Strong Medical Device (MD) clinical safety background
* Practical experience in MD benefit-risk assessment and MD risk management aligned with ISO 14971
* Expertise in safety activities related to MD clinical investigations or studies involving MDs
* Strong understanding and hands-on ability to apply ISO 14155
* Experience with combination products (drug/MD)
* Background in drug safety/pharmacovigilance is an advantage
* Scientific, healthcare or biomedical background with knowledge of MD regulations and technical aspects
The Role:
* Support and provide expert input into safety aspects of MD clinical investigations
* Lead the development of safety deliverables for MD studies, including CIP, IB, RSI and related documentation
* Serve as a subject matter expert for MD clinical safety within cross-functional teams
* Provide input into safety processes, SOPs, training, and the development of procedural documents
* Support audits, inspections, and due diligence activities relating to MD safety
* Collaborate globally with multifunctional teams across safety, clinical, regulatory, and risk management
* Stay current with MD regulatory trends, clinical safety practices, and evolving industry standards
If you're interested in this Medical Device Clinical Safety Specialist role, please apply below or contact Chloe McCausland on 01273 063769 between 8:30am - 5:00pm.