Are you looking for a new challenger where you can bring your skills to the frontlines of innovation? Our client is seeking a hybrid working individual to assist in Medical Devices Clinical Safety.
Proclinical is seeking a Medical Devices Clinical Safety Specialist to provide expertise and support across all safety-related aspects of medical devices, with a particular focus on clinical investigations. In this role, you will work collaboratively within diverse teams while also demonstrating strong self-leadership and independence. The position involves developing and providing safety input into key clinical investigation documents and leading the creation of safety deliverables for medical device clinical investigations.
Responsibilities:
* Provide safety expertise and input for clinical investigations of medical devices.
* Develop and contribute to core clinical investigation documents, including Clinical Investigation Plans (CIP), Protocols, Investigator Brochures (IB), and Reference Safety Information (RSI).
* Lead the development of safety deliverables for medical device clinical investigations.
* Conduct benefit-risk assessments and apply risk management principles in line with ISO 14971 standards.
* Ensure compliance with ISO 14155:2020 across all phases of medical device clinical investigations.
* Collaborate effectively within multifunctional and multicultural teams.
* Support vigilance activities and ensure adherence to medical device safety regulations.
* Provide expertise in combination products (drug-device) and their safety considerations.
Key Skills and Requirements:
* Expertise in medical device clinical investigations and related safety activities.
* Strong understanding and practical application of ISO 14155:2020 standards.
* Experience in developing safety input for clinical investigation documents such as CIP, IB, and RSI.
* Proven knowledge of medical device clinical safety, vigilance, and risk management per ISO 14971.
* Familiarity with combination products (drug-device) and drug safety/pharmacovigilance is advantageous.
* Background in healthcare, scientific, or biomedical research with clinical safety experience.
* Understanding of the technical and biomedical aspects of medical devices.
* Working knowledge of relevant medical device regulations and industry standards.
* Excellent communication, leadership, and teamwork skills.
If you are having difficulty in applying or if you have any questions, please contact Joshua Bye at j.bye@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.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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