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Regulatory Affairs Consultant Medical Devices
This vacancy has now expired. Please see similar roles below...
Proclinical is seeking a Regulatory Affairs Consultant Medical Devices to be based in France on a contract basis.
Job Responsibilities:
- Make a major contribution towards the preparation of any critical regulatory documentation for notifications in the Medical Device area and ensure that the company's products comply with relevant legislation and standards.
- Prepare submissions of license variations and renewals, set and communicate timelines for license variations and renewal approvals and write clear, accessible product labels and patient information leaflets.
- Generate records and documentation for inclusion into Technical Files and global regulatory submissions
- Working closely with the quality assurance and design teams you will have good knowledge of worldwide regulatory standards and demonstrable experience of ISO13485, CE marking, technical file submissions and of driving regulatory processes and activities.
- Recommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Skills and Requirements:
- Experience of working with active devices (IEC 60601, IEC 61010, IEC 62304)
- Excellent attention to detail
- Knowledge of compliance with key international standards such as ISO 13485, ISO 14971
- Ability to plan multiple tasks and effectively prioritize activities
- Experience in providing technical support and advice within a Medical Devices regulatory environment, preferable experience of liaising with competent authorities,
- Must speak French
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Jay Foster on +44 203 752 0309 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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