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Manager Regulatory Affairs (m/f/d) - Job Rostock, Homeoffice - CentoCareer

Manager Regulatory Affairs (m/f/d)

Welcome at CENTOGENE!

We, CENTOGENE GmbH ("CENTOGENE"), are the experts in rare hereditary diseases. We know the genetic basis and the clinical phenotype of genetic disorders inside-out. Our platform is based on the world’s largest curated mutation database for rare diseases. We have an unrivaled global diagnostic footprint, and an unmatched ability to derive diagnostic solutions to accurately identify rare disease patients and accelerate the path to approval for new orphan drugs.

How do we do this? By bringing together more than 500 individuals from 50 different countries to transform clinical and genetic data into medical solutions for patients. We work together at our HQ in Rostock, Germany, and also at additional offices in Berlin and laboratory facilities in Cambridge MA. Our employees - medical experts, scientists, IT professionals, bioinformaticians, technicians, researchers, project managers, and many more - are all passionate about one thing: improving the lives of our patients.

Does this sound like you? If it does, we’d love to hear from you.

Your tasks will be:

  • Implementation of regulatory strategies for worldwide market approval/registration for IVDs according to national legislation
  • Regulatory support during product development
  • Implementation of regulatory documentation
  • Registration of IVDs worldwide
  • Implementation / Improvement of RA processes: conformity assessment and product registration (worldwide), management of UDI, regulatory intelligence, performance evaluation, post-market surveillance

You have the following skills and qualifications:

  • Good knowledge of the regulatory requirements for IVDs, including software and laboratory developed tests, and quality management systems according to ISO 13485 and ISO 15189
  • Experiences in regulatory support of IVDs during product development until market approval based on EU and US legislations. Ideally experiences in Rest of World (RoW) counties are appreciated.
  • Experiences in writing regulatory product documentation for IVDs, e.g. EU technical documentation according to IVDR, Annex II + III, and registration of economic operators/ products
  • Experiences in the cooperation with regulatory authorities
  • Experiences in writing new / improving existing SOPs
  • Excellent communication skills
  • Highly analytical mindset paired with a structured, independent way of working
  • English business fluent

Those advantages are waiting for you at CENTOGENE:

  • Talents are individually supported by internal and external trainings
  • An international career in a multicultural environment
  • Regular company events form us as one team
  • In house yoga classes, back exercises and a fitness area are available for free
  • Lunch breaks and meetings on our roof terraces feel like vacation when looking at the Warnow
  • Bike leasing or job tickets allow an environmentally friendly and reasonable travel to work
  • In case of language barriers we offer German and English classes as well as relocation support
  • Precaution and financial protection guaranteed by company pension scheme

Applications from severely disabled people with appropriate suitability are explicitly welcome. Severely disabled applicants and equivalent status are given preferential consideration in the event of equal qualification.
Manager Regulatory Affairs (m/f/d) - Job Rostock, Homeoffice - CentoCareerManager Regulatory Affairs (m/f/d) - Job Rostock, Homeoffice - CentoCareerManager Regulatory Affairs (m/f/d) - Job Rostock, Homeoffice - CentoCareerManager Regulatory Affairs (m/f/d) - Job Rostock, Homeoffice - CentoCareerManager Regulatory Affairs (m/f/d) - Job Rostock, Homeoffice - CentoCareerManager Regulatory Affairs (m/f/d) - Job Rostock, Homeoffice - CentoCareer
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For those who embark on a career with CENTOGENE, they’ll enjoy an exciting, dynamic, entrepreneurial and extremely fast-paced environment. Working alongside dedicated colleagues, CENTOGENE employees enjoy other benefits including upskilling from a dedicated training department, yoga classes, company-sponsored bicycle leasing, German language classes, and new state-of-the-art premises conveniently located featuring roof terraces and an in-house fitness center. For employees new to Rostock we’ll also support on finding local housing.

Who we are

CENTOGENE is a rare disease company focused on transforming clinical, genetic, and biochemical data into medical solutions for patients. We are focused on bringing rationality to treatment decisions and accelerating the development of new orphan drugs by using our knowledge of the global rare disease market, including its epidemiological and clinical heterogeneity and our innovative biomarkers.

As one of the largest rare disease companies worldwide, CENTOGENE is dedicated to transforming the science of genetic information into solutions and hope for patients with rare diseases and their families. 

Contact

Anja Seidel
0381 80113 654