Ready to lead clinical safety and help bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!
À±½·ÊÓƵ is seeking a Medical Device Clinical Safety Specialist to provide expertise and support across all safety-related aspects of Class II and/or III medical devices, with a focus on clinical investigations. This role involves collaborating within cross-functional teams and independently leading the development of safety deliverables.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Oversee and lead clinical safety and vigilance activities for Class II and/or III medical devices, ensuring compliance with global regulations and internal standards.
- Manage the vigilance process, including adverse event intake, processing, assessment, and reporting to regulatory authorities.
- Review and contribute to core medical device study documentation, such as Clinical Investigation Plans (CIP), Protocols, and Investigator Brochures (IB).
- Develop and maintain Reference Safety Information (RSI) for clinical investigations, ensuring accuracy and timely updates.
- Conduct or contribute to benefit-risk assessments for medical devices, interpreting clinical safety data to inform decisions.
- Apply risk management principles in line with ISO 14971 to ensure safety in clinical processes.
- Serve as a subject matter expert for safety-related activities in medical device clinical investigations.
- Apply ISO 14155:2020 standards to the design, conduct, monitoring, and reporting of clinical investigations, focusing on safety reporting and subject protection.
- Provide guidance to clinical teams, investigators, and site staff on safety requirements for clinical investigations.
Key Skills and Requirements:
- Degree in a scientific field (Bachelor's, Master's, or PhD).
- Background in healthcare, scientific, or biomedical research with experience in clinical safety for medical devices or combination products.
- Strong understanding of the technical and biomedical aspects of medical devices.
- Knowledge of relevant medical device regulations and industry standards.
- Expertise in safety activities related to Class II and/or III medical device clinical investigations.
- Proficiency in applying ISO 14155:2020 standards in clinical investigations.
- Experience in developing safety documentation, including CIP, IB, and RSI.
- Demonstrated ability in benefit-risk assessment and risk management per ISO 14971.
- Excellent communication, leadership, and teamwork skills.
If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.
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