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Regulatory Affairs Engineer

  • Breas Medical
  • Göteborg
  • Publicerad: 16 juni, 2017
  • Fulltid

Breas Medical was founded in 1991 in Mölnlycke, Sweden, as an en­trepreneurial company that quickly developed to become one of the global leaders in home mechanical ventilation and sleep treatment. We successfully market the Vivo and iSleep product ranges, the Nip­py and Clearway brands, and the Z1 CPAP range, redefining CPAP use in terms of size, weight, and portability. Today we are a global company selling in more than 40 countries through our network of subsidiaries (Sweden, UK, Spain, Germany, USA) and highly specialized distributors. Our 150 employees are the backbone of the company. We all share the same passion for patients and customers which shows in how we approach customer service, prod­uct development, manufacturing, sales, marketing, quality and service.

If you want to make a difference to home care patients, welcome to join us as our new Regulatory Affairs Engineer!

 

 Regulatory Affairs Engineer

We are now recruiting a Regulatory Affairs Engineer (RA Engineer) or as we call it a “Standards & Technical Investigations Engineer”

As our RA Engineer you will play an important role in our engineering support department. As an RA Engineer you work closely together with R&D, Engineering Support, Product Management, RA/QA and other functions in the organization.

You will be our expert in standards applicable to our products and provide interpretations for product/technical specifications to meet the requirements. You perform GAP analyses when standards change and deliver strategies to ensure compliance.

Other important tasks will be to perform and support technical investigations and root cause analysis related to complaints and non-conformities on installed-base products. Your responsibility will be also to document and report findings in suitable format for internal use, authorities and customers.

Your key responsibilities

  • Participate in Standards Review Board meetings.
  • Establish and maintain the Breas Standards Library and perform GAP analyses when standards change and deliver strategies to ensure compliance.
  • Interface with third party test organizations, product and process standards compliance and evaluation for existing and new products and processes.
  • Promote the awareness of regulatory, customer and statutory requirements throughout the organization.
  • Conduct periodic review of products with regards to applicable standards and product documentation for the purpose of compliance.
  • Participate in project for continuous improvement of the company’s products during design, production and post market.
  • Support and provide data for CE marking and data for Technical Files
  • Lead and coordinate technical product investigations.
  • Perform and support technical investigations and root cause analysis related to complaints and non-conformities on installed base products.
  • Participate in risk management activities both pre- and post-market.
  • Contribute to a positive user experience by answering questions / problems from customers and sales teams
  • Collect customer feedback and document user experiences in a systematic way to fulfill requirements for Post Market Surveillance
  • Report to Management Review meetings and feedback insights from customer feedback into the lifecycle management process

Your qualifications

  • Graduation in Science/Engineering with at least 5 years of relevant working experience
  • Strong knowledge in technical/product standards and the relation to regulatory requirements for medical devices
  • Sound knowledge of application architectures and databases
  • Well structured

To be successful in this position you must have excellent communication skills. You have strong problem-solving skills and operate with ease in a cross-functional environment. You will be based in our Mölnlycke-based headquarter. You are reporting to our Engineering Support Manager.

We are looking forward to have your CV and a Cover Letter no later than 28 July to Recruitment Consultant Linda Andersson, Moveup Consulting AB at linda.andersson@moveup.se

If you have any questions please feel free to contact either Linda at + 46 (0)76 – 624 20 00 or Tom Bergqvist at + 46 (0)733 – 87 27 22.

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