QA / RA Specialist

Medicina Ltd designs, has manufactured, and distributes medical devices within the United Kingdom and internationally. Medicina is proud to be part of the HMC Premedical SPA group. The company has responsibilities as both Legal Manufacturer and the distributor of products. The Quality & Regulatory Affairs function is responsible for ensuring that the company operates in accordance with all applicable legislation and maintains its ISO 13485:2016 certification status.

The role of the Regulatory Affairs Specialist is to maintain and develop technical files in accordance with applicable regulations/directives and to register and maintain product registrations in the territories Medicina distributes products to.

Reporting to the QA/RA Manager and working within the QA/RA team this is a great opportunity to develop a career in the medical devices field.

Responsibilities:

To prepare and maintain technical files and support applications through the approval process.

To prepare and maintain product registrations in applicable territories, working closely with the sales team to ensure local rules are adhered to.

Supporting the sales team and customer services team, responding to regulatory queries raised by customer and prospects.

Working with manufacturing partners to ensure product testing and validation is conducted to ensure that products meet with legal or implied requirements and that suitably detailed reports are generated to verify the outcomes of testing.

Preparation and maintenance of Medicina product specifications.

Review sterilization validation reports and other supplier documents to ensure compliance and incorporate updated documents into the applicable technical files.

Responsible for the regular review of applicable standards to ensure that changes to standards are reviewed and changes are implemented.

Compile, review and maintain Risk Management Reports, Post Market Surveillance Reports, and Clinical Evaluation Reports.

To be involved in audits conducted by notified bodies and competent authorities as required by the company and in the absence of the QA & RA Manager.

Maintenance of Quality Agreements with contract manufacturing partners.

To provide general support to the QA & RA Manager, including completing any reasonable ad-hoc tasks requested by management.

To produce information and data for management reports relating to Technical File status, updates and gaps as required by the QA & RA Manager.

To advise the QA & RA Manager of changes in legislation directly affecting the status of Technical Files.

Management and control of the artwork and packing approval process ensuring that only the latest version of artwork is available.

We are looking for a new team member who ideally has 1-2 years of experience within medical devices. As well as being able to offer flexible working and hybrid working, our employer pension percentage is 8% and there are opportunities to increase annual leave days.

Job Types: Full-time, Permanent

Pay: £25,500.00-£27,000.00 per year

Benefits:

• Additional leave


• Bereavement leave


• Casual dress


• Company pension


• Free parking


• On-site parking


• Sick pay


• Transport links


Schedule:

• Day shift


• Flexitime


• Holidays


• Monday to Friday


• No weekends