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