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| Job Location | Coventry |
| Education | Not Mentioned |
| Salary | £40,000 - £45,000 per annum |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent , full-time |
Were looking for a talented Regulatory Affairs Officer to join the team of a privately owned manufacturer of medical products.In this role, youll audit, report and remedy against standards laid down by bodies such as CE, MHRA and ISOThe RoleAs a Regulatory Affairs Officer your responsibilities will include:* Ensuring the product portfolio complies with the quality standards laid down by the relevant authorities and registration processes; this will include liaising and negotiating with them.* Planning, undertaking, and overseeing product trials and regulatory inspections* Keeping up to date with changes in regulatory legislation and guidelines* Assisting the company in obtaining marketing permission* Outlining requirements for all documentation including labelling, storage, and packagingRequirementsThe ideal person for this Regulatory Affairs Officer role should have:* Regulatory affairs experience with specific exposure to ISO 90001 and 13485 as well as BSI* Familiarity with IVD regulations for CE marking in the EU, transition from IVD to IVDR, and UKCA qualification* Effective negotiation, analytical and problem solving skills.* A relevant degree in chemistry, physics, biochemistry, biotechnology, pharmacy, medicinal chemistry, biomedical science, life or applied science* A relevant postgraduate qualification (PhD or research-based MSc) may be advantageousIf youre an experienced Regulatory Affairs Officer looking to make a difference in the healthcare industry, wed love to hear from you. Coburg Banks Limited is acting as an Employment Agency in relation to this vacancy.