Senior Regulatory Project Manager - Contract - Medical Devices.
Location: Remote work; occasional travel to Yorkshire and /or North London Required
Term: 3- 9 month contract; competitive day rate.
Our Client, a multi sited Medical Devices/ Cosmetics Manufacturer is looking to recruit for an experienced RA Consultant to get them Brexit ready. Their products are subject to many changes driven either internally or through the changes to the external regulatory environment.
Examples of changes include:
- Change to CE marked medical devices
- Brexit related impacts (e.g. Authorised Representative updates)
- UDI / GS1 barcoding changes
- Additional Languages and product name changes
- Medical Device Regulation changes
Consequently, changes cause the labelling of their products to be frequently impacted and this often requires updates amendments or renewal to product registrations and approvals.
This role will have responsibility for co-ordinating and managing the consequences of labelling changes made to their products (including regulated products such as medical devices and biocides).
Reporting to Regulatory Affairs and Quality Assurance Director
- Co-ordination of changes impacting product labelling and registrations. Ensuring alignment between the various stakeholder functions (typically Regulatory Affairs, Quality Assurance, Operations, Artwork, External manufacturers and Commercial teams).
- Ensuring that changes impacting product labelling and registrations are co-ordinated throughout the process.
- Implementing both interim and long-term processes for co-ordinating changes to ensure that only products with the correct labelling/regulatory approvals can be ordered and shipped to customers.
- Will hold a Degree in a relevant Scientific discipline
- Be an RA Consultant (LTD/ registered company) with experience in the Medical Devices and/ or Biocides and Cosmetics.
- Project management qualification and significant experience.
- Awareness of operational / supply chain processes and controls
- Understanding of regulatory processes / product labelling
- Have experience in ensuring submission deadlines (Europe) are met