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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
