Our client (located in Berkshire, West of London) is considered by many as the market leader when it comes to the manufacturing and sales of diagnostic & medical instruments.
Established for over 100 years and with a recent considerable investment into the business, this is an exciting time to join this growing global brand.
Due to continued growth and new projects, we are looking for a Labelling Specialist with a Medical Devices background to join the Regulatory Affairs team. Reporting directly to the Senior Regulatory Affairs Manager some of your duties will include: -
- Review product labelling across all medical devices, ensuring compliance to international regulatory requirements (e.g. MDD/MDR, 21 CDR Part 801, ISO 15223-1 and EN/IEC 60601-1).
- Perform labelling gap assessments, develop project plans for updates and implement changes.
- Monitor changing global medical devices regulatory requirements and assist in the implementation of changes where required.
It is likely the successful candidate will have the following:
- Minimum 2 years Regulatory Affairs experience gained within medical devices.
- Knowledge of global medical device labelling requirements
- Working knowledge and practical experience of quality and regulatory guidelines as applied to medical devices.
- Strong communication and relationship building skills
- Be methodical, analytical and highly organised.
How to apply
If the above sounds like your ideal role and you have the skills and attributes as listed above, please don’t hesitate to apply today, using the appropriate tab.
Key words: Regulatory, RA, Reg affairs, Regulatory Affairs, Medical Devices, Labelling
- Communication Skills
- Medical Devices
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