QA/RC Specialist
Permobil AB / Civilingenjörsjobb / Timrå
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hela Sverige Permobil founder Dr. Per Uddén believed that helping people achieve the greatest level of independence is a basic human right and, for over 50 years, Permobil has held fast to that belief. Permobil is a global leader in advanced rehabilitation technology, passionate about better understanding our users' needs and improving their quality of life through state-of-the-art healthcare solutions. Today, those solutions include power wheelchairs, seating and positioning products, power assist, and manual wheelchairs.
Permobil.com (
http://www.permobil.com/en/Corporate/)The Quality Assurance & Regulatory Compliance team in EMEA is looking for a Regulatory Specialist.
What we offer
• An attractive workplace in a steady growing, international company with a focus on innovation and quality
• An exciting and challenging position in an open and dynamic environment with a lot of development potential
• Cooperation in an engaged and highly qualified team
Key duties
The QA Specialist in regulatory compliance (RC) is responsible for maintaining and supporting the Quality Management System to comply with relevant national and international standards and regulations e.g. Medical Device Regulation (MDR). You must be able to function well in a fast-paced and multi-task environment.
Furthermore, your duties will include:
• Perform regulatory assessments in the Design Control process
• Advise project teams on regulatory requirements, export and labeling requirements, and clinical study compliance.
• Identify relevant guidance documents, international standards and consensus standards to provide interpretive assistance.
• Assure compliance in response to changes in regulations or standards.
• Draft EU declarations of conformity and evaluate all necessary documentation needed for signing the EU declaration of conformity such as General safety and performance requirement checklists and Technical Documentation for compliant CE marking of our Medical devices.
• Review product promotional materials and labeling for compliance with applicable regulations and policies
• Investigate non-conformance issues and CAPA
• Identify training needs and organize training in Regulatory Compliance
• Participate in internal and external audits
• Interact with all parts of the company as well as competent authorities
Qualifications You have a university degree in science or engineering. You have working experience, preferably from Med Tech or Pharma industry and/or have good knowledge of quality management systems. As a person you are a team-oriented problem solver with strong organizing skills and attention to detail. You have great communication skills, which you will use both in investigations and when performing training. You are fluent in oral and written English, Swedish (other languages such as German and French would be beneficial)
The position can be based in one of our offices in Timrå or Kista. Information For more information about the position, contact Stefan Ståhlberg, Director QA & RC, +46 70 2720125 or
stefan.stahlberg@permobil.com For information about the recruitment process, contact Karin Frisendahl, Jefferson Wells, +46 70 377 45 46,
karin.frisendahl@jeffersonwells.seFor contact with union representatives, please email:
unionen@permobil.comPlease submit your application via our career page, no later than 28th February.
Varaktighet, arbetstid
Heltid Anställningstid enligt överenskommelse
Publiceringsdatum2021-02-12ErsättningLön enligt överenskommelse
Så ansöker duSista dag att ansöka är 2021-02-27
Klicka på denna länk för att göra din ansökanFöretagPermobil AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Permobil AB (org.nr 556113-3496),
http://www.permobil.com Arbetsplats Permobil
Jobbnummer 5572455
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