Have you gained a wide breadth of Regulatory Affairs experience within SME Pharma and/or Medical Devices companies? A market-leading Medical Device organisation has an opportunity for you to join their team based in Loudwater, South Buckinghamshire.
You’ll be responsible for supporting the QMS within the business ensuring compliance to ISO 13485, Medical Devices Regulations and other ISO standards. This will involve:
- Day to day management, co-ordination and creation of the technical documentation for Medical Device files
- Ensure timely product release to maintain continuity in the supply chain (sterile/non-sterile medical devices and one medicine)
- Ensure Good Distribution Practice is followed in relation to relevant processes (release, returns, storage, transport, logistics, vigilance).
- Be the Responsible Person for GDP and for Regulatory Compliance in line with Article 15 of the Medical Devices Regulation.
- Be the Management Representative in respect of ISO13485.
- Lead on training related to Regulatory requirements to all levels of staff within the business.
- Assist with investigating and managing customer complaints and to respond to technical enquiries relating to our products with assistance from third parties.
- Possess a degree in Life Sciences, Pharmaceuticals, Engineering or related subject.
- Proven Regulatory experience from Medical Devices/Pharmaceutical field.
- Ability to demonstrate Regulatory knowledge (MDD) in Class I and Class IIa devices as a minimum.
- Hands on experience of creating and maintaining technical files in accordance to MDD/MDR.
- Experience of working with ISO 13485 and ISO 14971.
- Experience of dealing directly with Notified Bodies and Competent Authorities such as MHRA.
Excellent salary and benefits package is offered including Private Health Insurance, Pension Scheme, Life Assurance, Subsidised café, Free On-site parking.
If you’d like to hear more about this role, please send us your CV by clicking ‘apply now’.Apply