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Manager Regulatory Affairs (m/f/d) - Job Rostock, Home office - 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:

  • Responsible for continuous CAP LAP accreditation (Laboratory Accreditation Program) accreditation and interaction with CAP
  • Licensing with relevant US states for clinical laboratories
  • Regulatory support and training for medical laboratories according to applicable national legislations
  • Communication with Authorities, Accreditation Bodies, Distributors and Customers
  • Preparation and maintenance of IVDR compliant documentation for in-house IVDs (Article 5(5), IVDR)
  • Support implementation of regulatory strategies for worldwide market approval/registration for IVDs according to national legislation
  • Support registration of IVDs in non-EU countries

You have the following skills and qualifications:

  • Experience in regulatory for medical laboratories in US and Germany
  • Good knowledge of the regulatory requirements for medical laboratories with respect to ISO 15189, RiliBÄK, Gendiagnostikgesetz (GenDG), GLP, GCLP and applicable parts of GCP
  • Knowledge of ISO 20387 for biobanking is preferable
  • Knowledge of regulatory requirements for in-house IVDs according to Article 5 (5), IVDR (EU) 2017/746  
  • Experiences in writing regulatory product documentation
  • Experiences in the cooperation with Authorities, Accreditation Bodies, Distributors and Customers
  • Experiences in registration of IVDs in non-EU countries is preferable
  • 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, Home office - CentoCareerManager Regulatory Affairs (m/f/d) - Job Rostock, Home office - CentoCareerManager Regulatory Affairs (m/f/d) - Job Rostock, Home office - CentoCareerManager Regulatory Affairs (m/f/d) - Job Rostock, Home office - CentoCareerManager Regulatory Affairs (m/f/d) - Job Rostock, Home office - CentoCareerManager Regulatory Affairs (m/f/d) - Job Rostock, 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