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Regulatory Affairs Manager (m/w)

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NEO New Oncology GmbH – part of Siemens Healthineers – is a dynamically growing diagnostics company offering genetic testing to identify optimal treatment options for cancer patients. Our technology platform “NEO” is based on next generation sequencing and proprietary computer algorithms. NEO reliably identifies therapy-relevant genetic alterations from standard clinical material such as FFPE specimens and liquid biopsies with short turnaround times and highest accuracy.

To expand our current capabilities we are seeking a highly motivated
 
Regulatory Affairs Manager (m/w)

We are looking as soon as possible for a skilled individual with experience in the pharmaceutical / medical device industry. You will work cross functionally being responsible for the regulatory aspects of the CE labelling of our in-vitro diagnostic products. Excellent English and German verbal and written skills are mandatory (German native speaker preferred).
                                                                                                                                                  
Your tasks:
  • Represent the regulatory affairs function and provide regulatory guidance and strategy for assigned products;
  • Plan, prepare and manage regulatory documents and submissions during development and life cycle management for assigned products;
  • Act as regulatory contact person for authorities, external partners and in-house functions;
  • Creation and maintenance of technical files, design control, risk management
  • Post market surveillance, vigilance reporting;
  • Keep current with the regulatory and scientific environment and support the creation of standard operating procedures;
  • Supervise employees, giving work direction and training;
  • Support the quality management department;
  • Reports to the Head of Quality Management.
     
Your qualification:
  • Degree in pharmacy, chemistry, biology, medicine or related discipline;
  • At least two years experience as Regulatory Affairs Manager in a pharmaceutical / medical device or IVD company;
  • Knowledge of ISO 13485, ISO 14971, IVDD regulations are required, prior experience with interacting with Competent Authority preferred;
  • IVD CE-Mark Annex II, List A or B with Notified Body interactions desired;
  • Experience in regulatory submission process of clinical studies favored;
  • Laboratory experience is a plus;
  • Organization and planning skills;
  • Communication, negotiation and interpersonal skills;
  • Ability to strategically plan, organize and manage multiple projects simultaneously;
  • Track record of creativity and problem solving in projects;
  • Sound knowledge of clinical study requirements;
  • Project management skills / training.
                                                                                                    

 

Kontaktdaten


Art des Bewerbungszugangs
Please send your application only by e-mail to jobs@newoncology.de. Please indicate the job title in the header of your e-mail.
Kontakt für Bewerbungen
Please send your CV, cover letter, academic transcript and testimonials to Bettina Schäfer, Head of Quality Management and Director of Clinical Operations.

Details der Stellenanzeige


Arbeitszeit
Vollzeit
Vertragslaufzeit
Festanstellung
Stellentyp
Fachkraft
Berufserfahrung
Berufserfahrung vorausgesetzt
Region
Deutschland (Nordrhein-Westfalen)
Arbeitsort
51105 Köln
Fachgebiet
Healthcare & Gesundheitswesen
JETZT BEWERBEN