Description: |
This world leading test and certification organisation is urgently seeking a Senior Engineer with a sound knowledge andexperience in the field of Medical Device Regulatory Compliance.Responsibilities associated with this position will include:1. Technical file assessments -class II a/b active medical devices.2. Providing technical input to on-site quality system audits.3. Reviewing technical assessment and quality system outputs to ensure that:* assessments have been carried out in accordance with the Notified Body procedures.* testing has been carried out in accordance with the requirements of the appropriate standard(s) or to otherrequirements that may be applicable.* assessments have been carried out by appropriately qualified staff within their area of expertise and authority.* subcontracted assessments have been performed satisfactorily, by an identified and approved subcontractor.* assessment report meets the requirements of the Notified Body, that it contains all the information required and thatthe information is valid and relevant, that the information is appropriately signed off and dated, that it is formattedcorrectly in English or such other language as has been agreed with the Company.* Action requests noted during assessment have been duly considered and have been subject to the appropriate correctiveaction.4. Support Marketing and Sales in promoting medical services and developing new clients.5. Assist in preparing and delivering public and private training sessions for customers.6. Assist and advise Customer Services in drafting quotations.7. Train junior staff as necessary.8. Provide 510k third party assessment capacity.To be considered for this position candidates must possess a degree (or equivalent qualification) in electricalengineering, physics or science and should have a sound industrial background (at least 5 years) in active medical devicedesign, development, manufacture or quality assurance.You will also need to have good working knowledge of the following standards/regulatory requirements:EN 60601-1(Electrical safety); EN 60601-1-1 (Systems), EN 60601-1-2 (EMC), EN 60601-1-4 (Software) and EN 60601-2-xx orother applicable standards relating to active medical devices, ISO14971 (risk management for medical devicemanufacturers); ISO13485 (quality systems for medical device manufacturers); Medical Devices Directive (93/42/EEC);21CFR820 - cGMP and 510k.Candidates must also be willing/able to travel internationally as required.Salary GBP 30,000 - GBP 40,000 depending on experience + excellent benefits package |
