Here at SRG, we partner with an established, global medical device company with a wide-ranging product portfolio. They are looking for an expert regulatory professional to join their company to provide regulatory support in a range of areas.
As a Senior Regulatory Affairs Specialist, your main objective is to review/analyse impact of modifications to manufacturing process, product, and packaging to the registration status of approved products and help determine the appropriate regulatory pathway, review/approve advertising & promotional materials, re-registration activities in support of US registrations. Some of your main duties and responsibilities include, but are not limited to, the following:
- Coordinate and submit licenses and authorizations for the maintenance of existing products, international registrations and dossiers, updates to DOC (technical files), engineering and device change requests.
- Research, collect data, and respond to requests from regulatory agencies to prepare and submit documentation for marketing approvals (US, Canada and EU), as well as to provide routine regulatory information to associates and affiliates.
- Provide regulatory guidance to product development teams and responds to product information requests.
- Represent regulatory affairs in cross-functional project teams and plans schedules for regulatory deliverables on a project and monitors project through completion.
- Prepare regulatory labelling requirements specifications for new and modified products; review product labelling for existing products to ensure compliance.
- Assist in the development of best practices for Regulatory Affairs processes.
- Provide Regulatory Affairs support during internal and external audits.
This role can be remote based but will require occasional visits to their Ripon site.
As the ideal candidate, you will have at least 7 years' experience in a regulatory affairs role, experience with technical files, regulatory registrations, recalls, MDR's, Vigilance reports and also have great understand of all relevant regulatory standards (EU, FDA, ISO, MDSAP). You must have good communication skills along with good working knowledge of manufacturing and quality operations. Knowledge of sterilization methods is advantageous.
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