Regulatory Affairs Engineer
Posted on Jul 4, 2019 by CV-Library
My client offers a global environment where entrepreneurial thinking is highly valued. You will be a part of a motivated and self-propelled team where you have the ability to influence the development of the company as well as your own career. Regulatory Affairs is the decision authority on regulatory, environmental and export control matters across the organization. The function proposes and implements company policy on regulatory issues such as: export control, trade compliance, labelling review, product registrations, standardization, regulatory strategy, radiation safety etc.
The Regulatory Affairs team is now looking for a Regulatory Affairs Engineer. The Regulatory Affairs Engineer works as part of the European team to support my client globally in the 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 Elekta’s business. The position is placed in Crawley.
* 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
Qualifications and experience:
To be successful in this role we would prefer solid experience in Regulatory Affairs. You have gained experienced at an industrial company 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. We also value your ability to apply your expertise to a variety of problems and being able to find smart solutions within the regulatory and quality area. Your English skills are excellent, both orally and written. You have a Master of Science degree (Mechanical, Electrical, Industrial Engineering, etc.) or equivalent engineering degree. We are looking for a regulatory affairs professional, preferably with experience in particular product submissions strategies and handling, or equivalent.