Senior Regulatory Affairs Engineer , supporting the Global organisation in the delivery of its products in a highly regulated environment. Regulatory Affair Engineer will work closely with Manufacturing, Supply Chain, R&D and Engineering.
This key role is the main interface and liaison point for the external regulatory authorities. This is a high impact role that works in a fast-paced dynamic environment and is essential to the business.
Senior Regulatory Affair Engineer is responsible for the following:
* Providing guidance on product regulation
* 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
Relevant Knowledge, skills and competencies
To be successful in this role you need to possess solid experience in Regulatory Affairs , gained experience at an industrial company working with manufacturing or product development, preferably in the MedTech or Pharma industry.
You should have had experience with quality assurance, compliance and experience from working with internal and external audits.
Problem solving and being able to find smart solutions within the Regulatory Affair and QA. Excellent communication skills both written and verbal, expected to have gained a Master of Science degree (Mechanical, Electrical, Industrial Engineering, etc.) or equivalent engineering degree . Regulatory Affairs professional, preferably with experience in particular product submissions strategies and handling, or equivalent. Highly valued personal qualifications and competencies are as following: