Are you looking for a position which can offer you great security, a market-leading salary and flexible working?
My client is seeking either a Regulatory Affairs Specialist who is looking to take the next step in their career, or a Regulatory Affairs Manager looking to transition to another medical device business.
This role will have you focus on global registrations, including 510(k) submissions, and working with the R&D team on developing new active devices.
• Liaise with QA/RA management throughout the global organisation to ensure consistent global approach to regulation compliance.
• Identify potential changes to regulations, review impact and make timely notification to the business to ensure compliance is maintained.
• Ensure current regulations and standards are available to Subject matter experts within the company and key stakeholders.
• Generate RA registration plans for new product developments, product changes and renewals.
• Maintain technical information related to the summary of technical documentation (STED), such as Declarations of Conformity (DofC), Device Master Records (DMRs) and any other which may be required as part of CE certification and registration activities.
• Support and supply information as required relating to Product Registration in any market where the company markets its products, especially MDSAP markets, including site /establishment registrations and product registrations, such as FDA 510(k) and EU CE Marking.
• Attend and support Design review activity and generate the required regulatory documentation for product certification purposes.
• University degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering or equivalent experience.
• 5 to 10 years’ experience in the medical device industry in product registration, medical device file and/or technical compliance activities.
• Good understanding of EU MDD/MDR, ISO 13485, FDA QSR, JPAL, MDSAP requirements and other key international regulations requirements and ability to communicate and provide training on these technical and regulatory documents to a less specialist audience.
Please contact Nathan Berkley on +44203 019 6020 or email email@example.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.
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