Regulatory Affairs Engineer
Dfind Science & Engineering AB / Kemiingenjörsjobb / Stockholm
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Dfind is now looking for a Regulatory Affairs Engineer to work on an assignment with our client. The client offers a global environment where entrepreneurial thinking is highly valued. You will be a part of a motivated and self-propelled European team where you have the ability to influence the development of the company as well as your own career. During this assignment you will be employed by Dfind. As our consultant you get a secure employment with collective agreements (Almega), fixed monthly salary and benefits such as healthcare, occupational health insurance, insurance, ITP pension and health care allowance.
Dfind Science & Engineering is a consulting and recruitment company specialized in science and technology skills. We arrange various events and training courses for our consultants that enable exchange of experience, networking and insight into working in different roles and companies. With us, you get a consultant manager who is committed to your assignment and career development.
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 clients 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 our clients 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.
Business: Dfind Science & Engineering
City: Stockholm
Job type: Full time
Deadline for applications: 2019-03-14.
More information: Julia Gonzales,
julia.gonzales@dfind.se We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! The contract might be filled before deadline application!
We put great emphasis on personal suitability for this role.
Organization/Business description:
Dfind Science & Engineering is part of Randstad, one of the Nordic region's largest specialists within staffing, recruitment and outplacement.
Dfind Science& Engineering is specialized in recruitment and consulting providing competences within Life Science, Science and Engineering and is a company where people make all the difference. At Dfind Science & Engineering specialists are recruiting specialists!
All our recruitment consultants , consultants and sourcing managers have a technical or scientific background, combined with extensive networks within relevant communities and expertise within recruitment and HR. We understand our customers specific requirements and know how to find the best candidates. Through our passionate commitment and high degree of attentiveness we help people and businesses to grow and be competitive in a changing world.
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2019-02-18ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-03-11
Ange följande referens när du ansöker: 201197421
Klicka på denna länk för att göra din ansökanKontaktIman Bagher
iman.bagher@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Regeringsgatan 65
11156 STOCKHOLM
KontorsadressRegeringsgatan 65, 11156 STOCKHOLM
Jobbnummer 4620300
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