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Regulatory Affairs Engineer (Refnr:437)

För kunds räkning söker vi nu en Regulatory Affairs Engineer, enligt nedan:
 
The Role
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: compliance, labelling review, product registrations, standardization, regulatory strategy, post market surveillance, radiation safety, etc.

The function Regulatory Affairs is now looking for a Regulatory Affairs Engineer. The Regulatory Affairs Engineer works as part of the European team to support the customers organization 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 customers business.

The position is placed in Stockholm.

Your key responsibilities are:
• Support the implementation of the new European Medical Device Regulation
• 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 in product maintenance
• Participate in product release process
• Participate in regulatory process improvements work

Is this you?
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 Medical devices 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 Bachelor of Science (Mechanical, Electrical, Industrial Engineering, etc.) or equivalent engineering degree. We are looking for a Regulatory Affairs professional, preferably with experience in product development and submissions strategies, or equivalent. 

In this recruitment, your personal attributes will be of great importance! We are looking for someone who has great communication skills and has the ability to work unsupervised under own initiative. We also see you as an analytic and flexible person in your way of working. Excellent problem-solving skills are also highly valued.
 
Years of experience
3
 
Skills
Solid experience in Regulatory Affairs
You have gained experienced at an industrial company working with manufacturing or product development, preferably in the MedTech or Medical devices industry
We value experience from working with quality assurance, compliance issues and experience from working with internal and external audits.

Start: Omgående
Placeringsort: 100% på plats hos kund, Stockholm