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QA/RA Manager

  • RLS Global AB
  • Göteborg
  • Publicerad: 20 december, 2018
  • Fulltid

Do you want to part of a very exciting entrepreneurial journey to establish RLS Global on the market?  Do you want to join a very competent team, a flat organistaion and also have fun while working? RLS Global is expecting an interesting development with high focus on global market penetration. We are now looking to extend and strengthen our competent team with a QA/RA Manager

RLS Global is a Medical Device company based in Gothenburg Sweden. The company is listed at Nasdaq, First North. The company was founded in 1997 with a strong R&D focus. RLS Global has two very exciting products, Carisolv and Perisolv, within the dental field. Since 2016 an important change is the transformation from a pure dental company, to a medical technology company with high expertise in wound care treatment. RLS Global is providing products within a fast-moving and dynamic environment.

This position has the overall responsibility for the QA/RA department at RLS Global. The position will report to the CTO but on regular basis attend the RLS Global management meetings.

At RLS Global we are a very experienced team who work in close collaboration to further develop the company and take it to the next level. Team spirit is a key word for us. The working environment is very dynamic.

Overall responsibilities:

Quality Assurance:
• Owner of the quality management system of RLS Global
• Secure the system, processes and procedures, are compliant according to current regulations
• Responsible for the compliant process
• Responsible for final release of products to the market
• Identify and report any quality or compliance concerns and take immediate corrective actions
• Take the lead and drive the new MDR implications
• Support the RLS Global production site to ensure quality and compliance
• Internal audit responsibility
• Main contact person for RLS Global notified body (Lloyds)
• Management’s representative

Regulatory Affairs:
• Mentor, coach and leader to the organization on activities within Regulatory Affairs
• Plan and drive new and changed product registrations in EU, US and the rest of the world
• The regulatory representative in new innovations, design projects and design changes to define regulatory requirements

Education and experience:
• Extensive knowledge  and experience (5-10 years) from ISO 13485:2016 QMS systems, CAPA, Compliant Handling and Post Market Surveillance systems
• Regulatory experience (5-10 years) interfacing with local- and international regulatory bodies, such as European Competent Authorities, FDA, Health Canada and others
• Experience to work in close cooperation with Notified bodies Technical filing and file submission experience
• Strong project management skills
• Ability to influence and make recommendations at multiple levels of the company and provide strategic recommendations
• Excellent verbal and written communication and presentation skills
• Fluently in English and Swedish
• B.Sc/M.Sc degree in life science, chemistry or similar
• Regulatory Affairs Certification (RAPS) would be considered an advantage

If you want to learn more, do not hesitate to contact Daniel Kremer, or email your CV and application to daniel.kremer@moveup.se !


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