Regulatory Affairs Engineer required by medical devices leader. This role will see you working as part of the European team to support the global delivery of its products in a regulated environment. You will work closely with business areas including manufacturing and supply chain, research and development and engineering. You will liaison with regulatory authorities. This is a high impact role that works in a fast paced dynamic environment and makes a meaningful contribution to our client's business.
- Provide guidance on product regulation and translate into meaningful business requirements
- Gain market access for our regulated products including submissions
- Communicate with regional and business teams and prepare responses on all governing agency actions
- Review promotional labelling
- Represent regulatory affairs in new product development as well as maintenance projects
- Participate in product release process
- Participate in regulatory process improvements work
- Solid experience in Regulatory Affairs.
- Experience working with manufacturing or product development, preferably in the MedTech or Pharma industry.
- We value experience from working with quality assurance, compliance issues and experience from working with internal and external audits.
- Master of Science degree (Mechanical, Electrical, Industrial Engineering, etc.) or equivalent engineering degree.
For a full consultation on this role please email your CV to Arc IT Recruitment.