Regulatory Affairs Engineer to Elekta

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The role
The quality and regulatory affairs department consisting of 10 persons is now looking for a Regulatory Affairs Engineer to support the Neuro product line. The position is placed either in Stockholm or Linköping based on preference.
Your key responsibilities will be the following:

Define product license requirements on different markets
Handling regulatory submissions and maintain related records
Represent regulatory affairs in new product development as well as maintenance projects
Labeling review
Participate in product release process
Participate in regulatory process improvements work
Suggest process improvement
Internal audits

Background and personal qualities
To be successful in this role we would prefer a minimum of 2 years of 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 independently
Ability to interpret authority regulations
Appreciate compliance work
Appreciate the role as specialist
Flexible
Analytical
Excellent problem solving skills

Application
To apply, please send your CV and cover letter to Peopletransition, to the following address cv@peopletransition.com , mark your application ?PT0018? in the mail subject heading. For further information please contact Paul de Belder, mobile 0702-599 272. We look forward to receiving your application no later than September 15th.

Publiceringsdatum
2014-08-27

Arbetstider och omfattning
Tillsvidare
Heltid

Ersättning
Fast lön

Så ansöker du
Sista dag att ansöka är 2014-09-15
Ange följande referens när du ansöker: PT0018
Ansökan kan skickas till e-postadress: cv@peopletransition.com

Företag
PEOPLETRANSITION

Adress
PEOPLETRANSITION
Saltmätargatan 11, 5tr
11359 STOCKHOLM

Kontorsadress
Saltmätargatan 11, 5tr
STOCKHOLM

Övriga kontaktuppgifter
Telefonnummer: 08-410 699 70
E-postadress: info@peopletransition.com

Jobbnummer
1976621

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