UKCA Regulatory Affairs Specialist

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce

Currently we are looking for a Regulatory Affairs Specialist, 

project name: UKCA compliance for Surgical Vision
 

Project Description:

The new UKCA regulations which were developed by the UK Competent Authority have to be fulfilled by medical device manufacturers for compliant product distribution of our Surgical Vision products in the UK after July 1st 2023.

Concretely, detailed task description without personal reference, which reveals the independency of the service provision

The scope of services includes the following tasks, which are independently performed by the external contractor:

- Development of change submission packages for submission to the UK Approved Body to obtain UKCA registration certificates for legacy products

- Development of NPI submission packages for submission to the UK Approved Body to obtain UKCA registration certificates

- Review of labelling for compliance with UKCA regulations

- Supporting QA on process development for the RA part in UKCA related processes

- Product registrations in the MHRA database - Development of UKCA Tech Files and UKCA DoCs for one of our European legal manufacturers

- Provide cross-functional guidance on UKCA regulations

- Supporting the UK responsible person on RA related activities

- Change impact assessments for UKCA requirements

- RA releases for UK in SAP

4. Possible timelines to be kept.

The overall goal is to achieve UKCA registrations and UKCA product compliance by July 1st, 2023.
 

Qualifications:

Education: Life science/engineering university degree preferred but also long-term Regulatory Affairs work in industry/Notified Bodies sufficient as qualification

Experience: 3-5 years Regulatory Affairs background (product registrations) in medical devices preferred (all regions accepted) but also Pharmaceutical or consumer Regulatory background accepted Willingness to do hands on Regulatory Affairs work

Strong attention to detail and accurate work required

Work in a cross-functional, international, diverse team Remote setting possible

English language knowledge required, more languages are an advantage

Being based in southern Germany is of advantage (onsite work required, remote work possible)

If you are interested in hearing more about our UKCA Regulatory Affairs Specialist role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!