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Director Quality Assurance and Regulatory Affairs

Do you want to contribute to improving the quality of life for children and young people with special needs by constantly focusing on quality and safety?

 

The Director QA/RA at R82 A/S will be responsible for all quality assurance and regulatory activities within R82 and subsidiaries, including regulatory approvals, quality management system compliance, product quality and process improvement. Besides she/he will together with the team provide guidance across the business to ensure the ongoing performance, safety, and compliance of R82 products.

The Director QA/RA will be working closely with the Quality and Regulatory Affairs teams in Denmark, Sweden, Poland and the US.

With direct report to the CEO of R82, the Director for Quality Assurance & Regulatory Affairs will work closely together with the cross-functional management team and functional departments to develop and improve the business results through processes and to secure compliance and conformity with relevant regulatives, directives and standards.

A selection of your tasks are:

  • Improve, develop, and implement QA&RA processes aligned with business strategic initiatives and priorities
  • Improve, develop, and implement the R82 Quality Management System (QMS) infrastructure and educate staff in functional departments and international subsidiaries
  • Provide leadership to all functional departments to ensure product quality and quality system compliance
  • Ensure product quality improvement and provide regulatory information and interpretation to the entire organisation
  • Drive the CE marking process and interact with national and international test bodies
  • Interface with FDA and other international regulatory agencies and notified bodies
  • Drive and implement regulatory strategies to meet product development and release schedules
  • Risk management (i.e. establish and maintain product risk analyses)
  • Perform statistical analyses, trending and reporting of customer claims, NCR’s and CAPA’s

The candidate is experienced with Quality and Regulatory work including managing submissions and preparing and managing audits from regulatory bodies – preferable from a MedTech, Patient Handling or Rehab company. From this experience, the candidate has gained solid knowledge of current medical device regulation in the EU, the US and Canada and experience from working with 13485 as well as the FDA QSR 21 CFR Part 820.

Furthermore, the candidate is used to working with quality across functions in a manufacturing company that works with R&D and New Product Introduction. International working experience will be an advantage.

It will be a great advantage if you are used to interface with international notified bodies and have strong skills in the interpretation of regulations, such as MDR, FDA, including documentation, files and CE marking. Knowledge of FDA 510k is an extra asset.

You have a Graduate degree in Engineering, Business, Healthcare or other related fields. A Postgraduate degree is considered an additional merit.

You are a person with a positive and collaborative working style and you communicate with transparency and visibility regarding KPI status tracking as well as ongoing/planned projects.

A team-minded and hands-on attitude and action-oriented working style are crucial for achieving the defined goals. You have a strong interest and understanding of the products, customer and user needs and business requirements.

R82 offers great opportunities for personal development and the possibility of contributing to the development of R82. You will contribute to improving the quality of life for children and young people with special needs by constantly focusing on quality and safety. You will play an important role in the company’s strategy to grow and bring new and innovative products to the market.

Travelling: 5-10 days e.g., travelling to sites in Poland and conferences.

Domicile: Gedved, Denmark

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Research Consultant Julie Philipsen, Unique Human Capital on M: +45 61 31 40 04. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
/ /
cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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