Regulatory Affairs Manager
Location: Omega Diagnostics, Alva, Clackmannanshire
Reports to: Group Operations Director
Direct Reports: None
Job Summary: To be aware of all the implications of current and future Regulatory Affairs issues that will affect the Omega Diagnostics Group plc companies.
To keep up to date with all current and future Regulatory Affairs challenges that face the Omega Diagnostic Group plc. companies.
To be aware of both the IVDD and the forthcoming IVD Regulations and their impact on all the group’s product and service provisions.
Where necessary to be prepared to direct FDA studies, submissions and other activities that would be required to enable the group companies to register facilities and pre market notifications.
Direct Country Specific Registrations, to facilitate the registration of Omega Group products in countries deemed important for Omega’s products to be marketed in.
REACH, WEEE, H&S to keep abreast of other relevant regulatory issues that impact on Omega Diagnostics business.
IFU/MSDS, to keep the company Instructions for Use and Material Safety Data Sheets up to date with all appropriate regulatory requirements.
Scientific qualification, degree or higher level degree.
Minimum of 5 years’ experience in an in-vitro diagnostic assay Regulatory Affairs environment.
Experience of working within an ANVISA and/or an FDA controlled cGMP environment.
Experience of working under regulatory, quality and design systems requirements as applicable for the in-vitro diagnostics industry.
Capable of working independently and creatively to achieve objectives.
Ability to direct and lead a team when required to do so to meet goals and timescales dictated by the market demand.
Technical competence and good problem solving and analytical skills.
Ability to communicate effectively.
Good inter-personal skills to establish and develop working relationships internally and externally.
Ability and willingness to travel and attend meetings and seminars to keep abreast of current and future regulatory requirements.
Ability and willingness to travel to other Omega sites and to engage with the local regulatory resources on-site.
Salary negotiable depending on the level of experience, relocation expenses will be considered for a suitable candidate.
Please forward your CV and application letter to Michael Gordon:
Group Operations Director
Omega Diagnostics Ltd
Hillfoots Business Village