Supervisor (Permanent, Contract) - Littleport, Cambridgeshire, United Kingdom - TribePost Ltd

Description

Full time, Permanent
Engineering, Health and Medicine, Manufacturing, Scientific
Omega Diagnostics Ltd are recruiting for a Regulatory Affairs Supervisor to join the team in Littleport, Cambridgeshire – CB6 1SE
Regulatory Affairs Supervisor

Contract:
Full time, Permanent
25 days holiday a year plus bank holidays, increases with length of service

• Company pension scheme, minimum 4% contribution
• Private healthcare after successful completion of the probationary period
• Enhanced Sick pay scheme
• On-site Parking
• Company events

To manage the Regulatory Affairs (RA) function in Omega Diagnostics to ensure it performs to a level that allows the organisation to meet all its regulatory responsibilities.

Regulatory Affairs Supervisor – Main Areas of Responsibility:

• Motivate the team to achieve potential through PDR's, regular 1:1's, and training or development. Regulatory Affairs activities providing guidance and support to the Omega Diagnostics Regulatory Affairs team.
• Planning, coordination, and management of regulatory documentation activities.
• Review and compilation of Medical Device Files (such as Technical Files, DHF) for Omega Diagnostics products to

ensure adequate compliance with regulations.

• Preparation of documentation in support of regulatory function, i.e., post-market surveillance reports, risk

Preparation of documentation in support of Omega Diagnostics regulatory submissions to comply with regulatory
authorities for registrations of products worldwide to gain marketing authorization.

• Notification to regulatory authorities, where applicable, of significant product changes to retain marketing

To liaise with partners and regulatory authorities to support regulatory submissions and vigilance activities.

• Review and approve product labelling, including instructions for use, container labels, packaging artwork, promotional

and training material for Omega Diagnostics products, as required.

• Implementation and maintenance of a UDI system.
• Maintenance of Regulatory procedures to ensure continued compliance.
• To ensure regulatory processes are followed and within required timeframes.
• Supporting internal and external audits to represent Regulatory Affairs positions and processes.
• Regulatory Affairs Supervisor – Knowledge, Qualifications & Skills:
• Knowledge of regulatory submission requirements for medical devices or IVDs in EU and MDSAP Countries (Canada, Brazil, Australia, USA)
• 5 year's experience in a regulatory position or professional qualification in Regulatory Affairs.
• Broader global regulatory requirements

take pride in building trust between ourselves and others
Registered Office: 36B Speirs Wharf, Port Dundas, Glasgow, G4 9TG