|Location: Crawley, West Sussex, England||Salary: £60000 - £65000 per annum|
|Sector: Medical Devices||Type: Permanent|
|Contact: Matt Henocq||Job Published: 9 days ago|
Regulatory Affairs Engineer
The Regulatory Affairs Engineer works as part of the European team to support the 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.
- 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 labeling
- 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 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 or equivalent.
- 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
Services advertised by Gold Group are those of an Agency and/or an Employment Business.