Regulatory Affairs Specialist

2 weeks ago


StokeonTrent, United Kingdom Brampton Recruitment Full time

* Relevant Life science or equivalent degree
- Minimum 2 years exp within medical devices or quality environment
- Experience of reading medical devices regulatory requirements
Our client is a global business that is specialists within their field. The company is a successful business that is currently undertaking an expansion; therefore, they are seeking an experienced Regulatory Affairs Specialist to join them. This role will beresponsible for ensuring regulatory products are registered in accordance with specific country's requirements and will involve liaising with external bodies regarding regulations.
**Job Description**:

- Creates and maintains global regulatory submissions to support timelines for new/modified product launches/registrations.
- Leads registrations and submissions for new and existing products.
- Ensures conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
- Provide Regulatory Affairs support during internal and external audits.
- Liaise with regulatory authorities and Notified Bodies as required.
- The report, assess and communicate any changes in regulations.
- Provides regulatory assessment on complaints.
- Support the Regulatory Affairs Manager in the creation and maintenance of procedures.
- Act as a mentor to junior regulatory staff members.
- Support and act as a delegate for activities falling under the remit of the Regulatory Affairs Manager.
- Relevant Life science or equivalent degree
- Minimum 2 years exp within medical devices or quality environment
- Experience in reviewing audit reports
- Experience in reading medical device regulatory requirements
- Strong time management skills, good prioritisation skills
- A medical devices qualification would be advantageous
Hours: Monday - Friday 9:00 am - 5:00 pm

**Salary**: Negotiable DOE
Brampton Recruitment is an independent Commercial and Accounts & Finance recruitment agency working in partnership with employers spanning Stoke on Trent, Staffordshire, Cheshire, and the Greater Manchester region.



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