Job opening – ‘Regulartory Affairs Manager’

Regulatory Affairs Manager

We are looking for an experienced, engaged, and proactive candidate with a background in Regulatory Affairs starting as soon as possible.

 

ARCEDI Biotech is a Danish biotechnology company focused on prenatal diagnostics and cancer. We have developed a method for cell-based non-invasive prenatal testing (cbNIPT). Our genetic test, offered as EVITA TEST COMPLETE, is available at private clinics throughout Denmark. ARCEDI is the first company to provide a genome-wide analysis of the fetus using circulating fetal cells.

 

ARCEDI is in the process of expanding its product portfolio and gaining access to private and public markets nationally and internationally. Therefore, we are looking for a regulatory professional who understands the national and international regulatory requirements and opportunities in relevant markets. You will contribute to developing and implementing a strategy that facilitates our access to more markets with our processes and products. Additionally, establishing knowledge of various national legislations regarding genetic testing will be part of the role.

 

Quality is an integral part of our company culture, and the role will involve assisting in continuous maintenance and improvement of the efficiency of our quality management system. This includes ensuring that ARCEDI complies with all relevant internationally recognized standards and regulations in every country where we conduct business.

 

We strive to operate with high quality in everything we do, while continuously improving our products and processes through research and ongoing optimization for the benefit of pregnancies and the societies we engage with.

 

Responsibilities:

  • Understand the regulatory requirements and opportunities in relevant markets for ARCEDI’s products and determine the regulatory way forward.
  • Understand national legislations regarding genetic testing in relevant markets and describe how we can operate within the regulatory framework.
  • Develop and execute a strategic plan, including IVDR and MDR.
  • Investigate regulatory requirements for the USA/FDA and assist in developing the strategy for establishing our business in the US.
  • Be an active part of the quality team and closely collaborate with the quality manager.
  • Assist in driving daily QMS work, with the possibility of process ownership.

We expect that within 3-4 months, you will be self-sufficient in regulatory work, and within six months, you will have a solid understanding of quality work.

 

The ideal candidate has the following qualifications:

  • Relevant education (B.Sc. or M.Sc.) or equivalent in a relevant scientific discipline.
  • Minimum of 5 years of experience in relevant Regulatory Affairs positions.
  • Strong knowledge of regulations, standards, and guidelines within medical laboratories, including direct experience with IVDR, MDR, FDA requirements, as well as ISO 15189 and ISO 13485.
  • Experience with international registration applications is an advantage.
  • Experience in RA/QA within genetic testing is also a plus.

We prefer that you have an eye for detail, strong communication skills, and are proficient in written English. Additionally, a positive attitude, comfort in a dynamic work environment, and the ability to work independently and in interdisciplinary teams are desired.

 

At ARCEDI, we offer:

  • An exciting job with significant decision-making opportunities, where you will play a central role in shaping the company’s regulatory strategy with the current quality team.
  • Flexible working hours and the possibility of hybrid work.
  • An interdisciplinary and dynamic work environment.
  • A relaxed workplace prioritizing professional development.
  • Lunch, free phone, free parking, and company-sponsored social events.
  • Competitive salary based on qualifications.

The position is for 32 or 37 hours per week, typically scheduled Monday-Friday between 8:00 am and 4:30 pm. The workplace can be hybrid, but it is an advantage if you are physically present at ARCEDI’s address in Aarhus eg. 2-3 days per week.

 

Salary to be negotiated.

 

Interviews are being conducted continuously. We conduct two rounds of interviews including a relevant case and DISC profile.

 

If you have any questions about the position, you can email Lotte Hatt at loha@arcedi.com

If you would like to apply for the job, please send us your material at hr@arcedi.com subject ‘application for Regulatory affairs manager’.

We look forward to hearing from you.”