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Post Market Surveillance Manager

2 months ago

Oxford Oxfordshire, United Kingdom Bond Williams Limited Full time
Are you ready to make a meaningful impact in the diagnostics industry? We're seeking a dedicated individual to join our client's team as a Post-Market Surveillance Coordinator. Reporting to the Regulatory Affairs Manager, you'll take on the crucial responsibility of coordinating all required post-market activities, ensuring compliance with regulatory reporting timelines, and fulfilling our post-market obligations.

As Post Market Surveillance Manager key responsibilities: * Coordinate post-market surveillance tasks aligned with QMS policies and international regulations. * Ensure individual product Post Market Surveillance plans are implemented effectively. * Collaborate with technical services and strategic partners to gather and manage PMS information. * Coordinate cross-functional teams for thorough investigations and reporting. * Establish and maintain sources for gathering customer feedback and product field performance monitoring.

What We're Looking For: * Minimum 3 years of experience in regulatory affairs within the diagnostics industry. * Strong knowledge of IVD device regulations, including 21CFR, IVDR, and ISO 13485. * Excellent communication, writing, and problem-solving skills. * Ability to work effectively in multidisciplinary teams and make informed decisions. * Understanding of when to escalate issues and strong persuasion skills.

Benefits: * Competitive salary * Attractive bonus * Generous pension contributions * Private healthcare Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency

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