Regulatory Affairs Co-ordinator Cambridge Salary based on skills, experience and sector backgroundGenuine opportunity for someone looking to further their Regulatory Affairs skills and knowledge
Our client is a global provider of genetic research solutions, working closely with leading clinical and academic institutions. They work with a worldwide collection of customers to provide a bespoke and unrivalled service within the ever growing and interesting genomic medicine sector.As a result of their ongoing growth plans, they are looking to appoint a Regulatory Affairs Coordinator to join their busy and exciting RA team in Cambridge. Providing essential RA support, you will play an active role in meeting the business and regulatory compliance requirements of their customers and respective markets.
Reporting directly to the Regulatory Affairs Specialist, your range of duties will involve the following:
* Maintain a strong knowledge of specific regulatory frameworks relevant to the market* Play an active role in ISO13485 audits, supporting the QA team* Produce and update all necessary regulatory documents* Support registration activities * Maintain IFUs and ensure they reflect product information* Ensure up to date knowledge of company product range regarding the technical and scientific environment, clinical purpose and regulatory framework* Review and approve labelling to ensure regulatory compliance* Work closely with external suppliers, distributors and international regulatory agencies to provide documentation, handle queries and issues and effectively manage complaints
Ideal candidates will have the following:
* Degree or equivalent in a relevant technical or Life Sciences field* Proven experience of working within a regulated IVD environment* Some experience of working to ISO 13485 and 21CFR 820 Quality system Regulation* Proven knowledge of working with regulatory documentation for global regulatory submissions* Working knowledge of medical device adverse event and recall reporting regulations
This is an ideal and genuine opportunity for someone who is looking to make the next step in their Regulatory Affairs career. It would be an ideal next step for a Document Controller or entry level RA candidate looking to further their knowledge and skills.Candidates must demonstrate strong attention to detail, be self-motivated and show flexibility to manage different projects.
If you think this sounds like an interesting and exciting next step in your career, then apply now by attaching your CV in Word.
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