Regulatory Affairs Manager (IVDs) (m/f/d) in Rostock, Berlin or Home Office
Welcome to CENTOGENE!
CENTOGENE’s mission is to provide data-driven, life-changing answers to patients, physicians, and pharma companies for rare and neurodegenerative diseases. We integrate multiomic technologies with the CENTOGENE Biodatabank – providing dimensional analysis to guide the next generation of precision medicine. Our unique approach enables rapid and reliable diagnosis for patients, supports a more precise physician understanding of disease states, and accelerates and de-risks targeted pharma drug discovery, development, and commercialization.
How do we do this? By bringing together more than 400 individuals from 50 different countries at our HQ in Rostock, Germany, as well as our offices in Berlin, Belgrade, and laboratory facilities in Cambridge, MA. Our employees are medical experts, scientists, IT professionals, bioinformaticians, technicians, researchers, project managers, and many more – and are all passionate about supporting our company vision : A world healed of all rare and neurodegenerative diseases.
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 (also known as Laboratory Developed Tests) within the framework of the quality management system according to ISO 13485, ISO 15189, 21 CFR 820 and IVDR (EU) 2017/746 regulation.
- Create and maintain the technical documentation for in-house IVDs according to Regulation (EU) 2017/746.
- Track and communicate regulatory and normative changes.
- 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
- Professional experience in the field of regulatory affairs for medical devices, ideally in the field of in vitro diagnostics is mandatory
- Experience in laboratory environment and knowledge of lab processes is a strong benefit
- Sound knowledge of the relevant European and international regulations such as IVD Regulation (EU) 2017/746 and related 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.
Scope of activities
OtherCareer level
ProfessionalLocations
Alboinstraße 42, 12103 Berlin, GermanyAm Strande 7, 18055 Rostock, Germany
Home office
Employment type
Full timeFor 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.
