Role: Regulatory Affairs Specialist UK/Ireland
Attractive salary + package
You will be expected to work across all therapy areas within the companies extensive product portfolio. Utilising your regulatory knowledge to support the activities driven by the regulatory changes and advise the local teams on regulatory aspects of their projects.This includes communicating directly with multiple internal and external stakeholders such as the central Regulatory Affairs function who are based in Europe, relevant members of the local UKI organization, and the MHRA.
The role also includes responding to a wide range of regulatory inquiries, and post-market activities including field safety corrective actions. You will be part of the Quality And Regulatory Affairs community in EMEA, with opportunities of career growth and training to ensure knowledge is up to date with regulations, procedures and processes.In this role, hybrid working is offered, that being working in both the Watford office and the home environment.
Main Job duties / responsibilities
Responsibilities may include the following and other duties may be assigned:
Keeping abreast of regulatory changes and liaising with Regulatory and Quality contacts in EMEA and Corporate to ensure UK and Ireland regulatory requirements are met and procedures updated accordingly
Post Market Surveillance (PMS) activities in the region Post Market Surveillance (PMS) activities in the region, including the execution ofProduct Field Safety Corrective Actions (FSCA)
Provide training and education on Regulatory Affairs topics both internally and externally as required
Resolving regulatory inquiries from both internal and external stakeholders
Must Have (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume.
At least 2-3 years of regulatory knowledge including a solid understanding of the EUMDR
Strong communication skills
Post market experience
Collaborative and positive spirit, adaptable and open for change
Competent in Microsoft Office suite
If you are interested then please apply or email directly at firstname.lastname@example.org
- Agency: Cpl Life Sciences
- Reference: JO-2204-491570
Website: Cpl Life Sciences
- Posted: 28th April 2022
- Expires: 26th May 2022