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Regulatory Affairs Manager (IVDs) (m/f/d)  in Rostock, Berlin or Home Office - Job Rostock, Berlin, Home office - CentoCareer

Regulatory Affairs Manager (IVDs) (m/f/d) in Rostock, Berlin or Home Office

Welcome to 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, Belgrade 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:

  • Manage the regulatory strategy for global regulatory compliance of in-house IVDs.
  • Create and maintain the technical documentation for in-house IVDs according to Regulation (EU) 2017/746.
  • Track and communicate regulatory and normative changes.
  • Support the QM team in maintaining the quality management system according to ISO 13485, ISO 15189, and 21 CFR 820.
  • Provide training and regulatory guidance to company staff and assistance in addressing regulatory issues with distributors and clients.

You have the following skills and qualifications:

  • Completed scientific or technical degree or comparable training
  • Initial professional experience in the field of regulatory affairs for medical devices, ideally in the field of in vitro diagnostics.
  • Sound knowledge of the relevant European and international regulations and guidelines is preferred.
  • Structured, responsible, and solution-oriented work approach.
  • Business fluent English skills, written and spoken
  • High communication and teamwork skills

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 support in finding accommodation to help you get going
  • 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.
Regulatory Affairs Manager (IVDs) (m/f/d)  in Rostock, Berlin or Home Office - Job Rostock, Berlin, Home office - CentoCareerRegulatory Affairs Manager (IVDs) (m/f/d)  in Rostock, Berlin or Home Office - Job Rostock, Berlin, Home office - CentoCareerRegulatory Affairs Manager (IVDs) (m/f/d)  in Rostock, Berlin or Home Office - Job Rostock, Berlin, Home office - CentoCareerRegulatory Affairs Manager (IVDs) (m/f/d)  in Rostock, Berlin or Home Office - Job Rostock, Berlin, Home office - CentoCareerRegulatory Affairs Manager (IVDs) (m/f/d)  in Rostock, Berlin or Home Office - Job Rostock, Berlin, Home office - CentoCareerRegulatory Affairs Manager (IVDs) (m/f/d)  in Rostock, Berlin or Home Office - Job Rostock, Berlin, Home office - 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