Senior RA Consultant

Regulatory Affairs
Copenhagen
Flexible remote working

 At Key2Compliance we help our customers succeed by offering consultant services and training for the medical devices and the pharmaceutical industries. At Key2Compliance you will be a part of a team that helps innovative companies develop their products from idea to success across the globe. Together, we can give our clients the most qualified support available.

Since 1994, we have focused on patient safety and helped organizations develop safe and successful products that give aid to individuals in their everyday life. Join our team of highly engaged co-workers, in a great atmosphere with every opportunity to grow and develop in the industry.

About the role

As a senior RA-Consultant you will contribute to our customers regulatory work, be a problem solver but also take on roles such as RA Manager and Project Manager. You will contribute to our education courses and will be a part of our mentorship program. Apart from working with other members of the QA/RA team, you will also be able to collaborate with colleagues in the Clinical Development, Training and BioComp teams.

Each consultant usually has between 2-3 projects simultaneously with clients in the small to medium-sized segment. The assignments consist of everything from short-term projects to longer assignments, giving you an interesting variety in your daily work.

About you

We believe you are highly interested in learning new things and have the ability to adapt when the situation changes. You are well-structured, organized and analytic. You enjoy problem solving and thrive off challenges. You have strong communication skills both in Swedish and English and believe that teamwork and sharing knowledge leads to the best results.

Key responsibilities

Consulting

  • Build technical documentation
  • Qualifying and classifying products in applicable markets
  • Identifying applicable standards and guide documentation
  • Support clients in working according to a product development process
  • Lead risk management
  • Investigate requirements in markets outside EU
  • Register the client’s product in different countries and engage with corresponding authority, distributor/agent
  • Support with follow-ups from authorities
  • Updating documentation according to new/changed regulations i.e. MDR/IVDR

GAP analysis

  • Conduct GAP analysis for the client’s technical file and product documentation

Qualifications

Education Requirements/Certifications

  • Masters or bachelor’s degree in relevant field or have through work acquired relevant knowledge

Required knowledge/skill

  • Full professional written and oral communication skills in English

Experience Required

  •  Minimum of 5 years’ experience within Regulatory Affairs

Information and contact details

Place of employment: Copenhagen, Denmark
Scope: Full time
Questions: Please contact Director Regulatory Affairs Team, Helena Dahlin, helena.dahlin@key2compliance.com
Other: We screen the applications and hold interviews continuously so please send your application as soon as possible.

We look forward to receiving your application!

Read more about us here!

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