Regulatory Affairs Specialist
Chester, Cheshire West and Chester, England
Permanent (Full time)
The role is based in Chester, with two days a week on site and the rest working from home.
You would be responsible for product authorisations and registrations in RoW territories. The company how three new products about to launch and you would oversee their launch and introduction into RoW territories. As a Regulatory Affairs Specialist RoW your main responsibilities and tasks would include:
To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for devices, particularly in RoW territories
Communicate to management any changes in regulations or requirements that have been identified
Work with in-country distributors or contractors to determine regulatory requirements for product registrations in responsible regions.
To ensure all authorisations / registrations related to established products are maintained
Monitor pending submissions to ensure timely approvals. Communicate to management any identified delays that may impact business expectations
To interact with regulatory consultants, regulatory and trade associates and other third-party service providers to ensure their provision of any requested activities to agreed timescales
As the ideal candidate you will have 2-3 years' experience in a regulatory affairs role within the medical device industry (or similar), knowledge of RoW Regulatory legislation and guidelines. Experience of working in an office environment and with both internal and external suppliers/customers along with a university degree in a scientific field is essential.