Regulatory Affairs Engineer

Regulatory Affairs Engineer

Description -

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.

Responsibilities -

• 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
• Flexible
• Analytical
• Excellent problem solving skills

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview. For a copy of our privacy policy please visit our website.