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| Job Location | Manchester |
| Education | Not Mentioned |
| Salary | £60,000 - £75,000 per annum |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent, full-time |
Role: Senior Regulatory Affairs Consultant - Medical Devices (Home based!)Location: EU / USASalary: Highly Competitive - Perm / Full TimeRussell Taylor Group has a fantastic opportunity for a Senior Regulatory Affairs Consultant who specialises within the Medical Device industry. You will be a highly experienced Medical Device expert with over 10 years experience in the industry. This is an excellent opportunity to join a Global Certification, Test and Inspection company.Role:· You will provide excellent Regulatory Affairs consulting services (e.g. Regulatory pathways for major global markets, pre-submission and clinical strategy support, clinical evaluations, management of technical documentation).· Conducting in depth training programs and public/client sessions on quality and regulatory related topics as well as standards and awareness trainings.· Customizing consulting solutions to clients specific needs (on-site and off-site)· Participating in the development and maintenance of internal Emergo programs and processes· Reviewing marketing material for accuracy (e.g. written documents and website content)· Providing guidance to Business Development (e.g. in determining scope and budget of proposals)Person:· You have an academic background in a scientific field (e.g. Biochemistry, Biological Engineering, Chemistry or similar).· You have gained at least 10 years of experience working in Regulatory Affairs in the medical device or diagnostics industry.· You have thorough knowledge and understanding of medical device quality system requirements (e.g. FDA QSR, ISO 13485, MDR/IVDR).· Expertise in IVDs is considered a plus· You are able to speak in depth on ISO 14971 requirements· Business fluent in English; fluency in other languages (e.g. Dutch/French/German) is considered an advantage· You are able to communicate effectively with all levels of hierarchy What can we offer youCompetitive renumeration & bonus packages, possibility to work remotely, and much more! To apply, please use the button below.Job Types: Full-time, PermanentSalary: £65,000.00-£75,000.00 per yearImportant Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k Required skills
Keyskills :
Medical Devices RA Consultancy