Do you have experience of working in the Medical Device Industry?
Do you have experience of working in Regulatory Affairs?
Are you looking to develop your career?
If so, this could be the opportunity for you!
I am working in partnership with a leading manufacturer of medical devices they specialize in innovation of new products, using their unique technology platform.
This year, they have had a delivered a strong first half performance, increasing sales of their products globally.
A vacancy has now arisen for a Regulatory Affairs Associate to join their team.
The Role: Compile, review and maintain regulatory submissions, Technical Files, and labelling for completeness and quality.
Maintain and update dossiers for existing Marketing Authorizations.
Identify regulatory requirements for new product and changes to existing products.
Determine the scope of information/documentation necessary to file new registration applications and post-approval changes to regulatory agencies.
Contribute within new product development projects to ensure compliance with internal product commercialization process and global regulations.
Review and approve product labelling/marketing materials for compliance with applicable regulations and standards.
Review new and existing EMEA regulations, guidance documents and standards, and prepare comments based on impact to product and business.
Support post-market surveillance and vigilance activities, including submitting reports to authorities.
The Candidate: Degree, or equivalent qualification, in a Life Science.
A strong working knowledge of Medical Device regulatory affairs environment including but not exclusive to:?
Regulations, Submissions and Technical Files.
Experience of communicating with Regulatory Authorities and Distributors?
Experience in clinical trials, specifically regulatory activities, and submissions for the trials Experience in regulatory audits, ISO certification, GMP requirements and document control.