Regulatory Affairs Engineer, Medical Systems
Excellent Salary + Excellent Package, including contributory pension scheme, healthcare and full and comprehensive industry recognised training.
**An excellent opportunity for an experienced Marketing professional with a background in the marketing of Product Lifecycle Solutions, Service Contract Sales and Renewals, or general marketing experience gained within a technology or engineering based organisation, to join a market leading manufacturer of sophisticated multi-million pound medical systems**
The Company - Regulatory Affairs Engineer, Medical Systems
My client is a worldwide supplier of sophisticated medical systems, and are a prominent provider of equipment to both diagnose and fight cancer.
This instantly recognisable market leader is well known for their innovative products and solutions, and provides a complete portfolio of integrated solutions for the healthcare sector. They have representation in over fifty five countries worldwide, and offer 'best in class" solutions across their highly sophisticated product range.
The Role - Regulatory Affairs Engineer, Medical Systems
The Regulatory Affairs Engineer works as part of the European team to support this organisation 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 the business.
Your key responsibilities will be the following:
- 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
Your Background - Regulatory Affairs Engineer, Medical Systems
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.
Highly valued personal qualifications and competencies are as following:
- Excellent communication skills
- Ability to work unsupervised under own initiative
- Ability to interpret authority regulations
- Ability to mentor and lead problem solving
- Appreciate compliance work
- Appreciate the role as specialist
- Excellent problem solving skills
Benefits - Regulatory Affairs Engineer, Medical Systems