My client, a Top 10 pharmaceutical company, are currently searching for a Regulatory Affairs Consultant to join their team based in Hertfordshire on an initial 12 month contract basis - homebased!
Within this role you will be responsible for:
- Develop and maintain country specific product regulatory processes including device registration, data/record management, post market surveillance and vigilance
- Compliance with and implementation of Global Quality and Regulatory processes
- Communication with National
- Competent Authorities
Experience:
- Regulatory Affairs experience in Medical Device Industry
- Working with Notified Bodies
- Post market experience
- Medical Device Registration
- Understanding of the current IVD Regulatory Framework and processes, UK and EU
- Technical Product knowledge
- Training Experience - IT systems and product
- Working with confidential information
- Communication with Competent Authorities
- Monitoring of Regulatory requirements
- Review and implementation of new legislation/regulations applicable to UK and Ireland
- Develop and maintain a comprehensive understanding of the current and future regulatory landscape, attending conferences to keeping up to date with developments in the appropriate laws and guidance
- To establish and maintain effective communications with the Competent Authorities in UK and Ireland ensuring compliance with the requirements of these competent authorities.
- To ensure all products are registered with the competent authorities as defined by the IVD Regulations.
- To work with EEA/Global colleagues to ensure compliance with Quality Management Systems and processes.
- To keep up to date with current Legislation and ensure compliance.
- To assist the Regulatory Affair Manager in the development, planning and execution of project work with the aim of improving the Regulatory Affairs function.
Required Experience:
- Extensive professional experience in Regulatory Affairs in the medical device or diagnostics industry
- Expertise in IVDs preferred
- Thorough knowledge and understanding of medical device quality system requirements (e.g. ISO/MDR/IVDR/UKMDR)
- Working with Notified Bodies
- Medical Device Registration
- Understanding of the current IVD Regulatory
- Framework and processes, GB and EU
- Working with confidential information
- Knowledge and understanding of regulatory affairs, especially European and GB regulations governing product safety, ideally with demonstrable experience as a regulatory specialist in industry or consultancy
- Submission and maintenance of regulatory documentation
- Communicating with competent Authorities
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk
- Agency: Achieva Group Limited
- Reference: BH-33185-1
Website: Achieva Group Limited
- Posted: 6th June 2022
- Expires: 4th July 2022
