Senior Regulatory Affairs Engineers

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Senior Regulatory Affairs Engineers

Our medical device manufacturing client based in Crawley, West Sussex are looking for a Senior Regulatory Affairs Engineer to join them on a permanent basis.

Job Description

The Company
Our 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.

Responsibilities:
The role
Regulatory Affairs is now looking for a Regulatory Affairs Senior Engineer. The Regulatory Affairs Senior 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. The position is based in Crawley.

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

Qualifications:
Background and personal qualities
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
" Flexible
" Analytical
" Excellent problem solving skills

Advanced Resource Managers Engineering Limited operates & advertises as an Employment Agency for permanent positions and as an Employment Business for contract/temporary positions.

Key Consultant

Darren Puddephatt

darren p

My areas of expertise are automotive OEM, consultancy, tier one suppliers and medical engineering, within mechanical and electrical engineering. I have been successful placing engineers, from graduate to chief engineer level within automotive engineering, covering controls and electronics, chassis engineering, body engineering, test and development engineers on various commodities.