Supervisor - - Permanent - Full Time

2 weeks ago


Witchford Cambridgeshire, United Kingdom Omega Diagnostics Ltd Full time

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 -
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 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
No agencies please.



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