Regulatory Affairs and Post-Market Compliance Officer, Diagnostics - UK

Hartmann Young has partnered with a leading global provider of innovative IVD solutions aimed at enhancing patient care through advanced testing technologies. With decades of industry experience, the company offers a range of products designed to improve lab efficiency and support clinical decisions by providing accurate and timely results.

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.

Responsibilities:

• Serve as the primary contact for regulatory compliance issues.
• Lead post-market surveillance activities and document preparation (PMS Plan, SSP, PMS Report, PSUR).
• Manage vigilance processes and coordinate incident reporting (FSCA, FSN, MDR, BPDR).
• Liaise with Competent Authorities for incident reporting.
• Contribute to regulatory inspections and audits.
• Stay updated on evolving regulatory standards.
• Support and train team members on compliance practices.

Requirements:

• 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).
• Strong communication, analytical, and time-management skills.
• Ability to work independently under tight deadlines.

If this position is of interest to you, please reach out to me for a confidential discussion at: oskar.bednarczyk@hartmannyoung.com.