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Markets Compliance Officer

2 months ago

England, United Kingdom Hartmann Young Full time

Hartmann Young has partnered with a leading global provider of innovative IVD solutions aimed at enhancing patient care through advanced testing technologies. As a Regulatory Compliance Officer you will play a critical role in bridging the gap between product compliance and the end user. As part of the Quality and Regulatory Affairs team, you will ensure all regulatory requirements are met, with a focus on post-market surveillance, vigilance reporting, and compliance.

Serve as the primary contact for regulatory compliance issues.
Contribute to regulatory inspections and audits.
Stay updated on evolving regulatory standards.
Support and train team members on compliance practices.

Relevant degree or experience in regulatory affairs.
Expertise in medical devices, IVD, or biotech industry.
Knowledge of regulatory frameworks (93/42/EC, 98/79/EC directives, FDA 510(k), PMA).