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Regulatory Affairs Manager (m/w)

Workscope: Regulatory Affairs
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 Regulatory Affairs Manager with experience in the IVD / medical device industry. You will work cross functionally being responsible for the regulatory aspects of our in-vitro diagnostic and software products. Excellent English and German verbal and written skills are mandatory (German native speaker preferred).

Tasks:
  • Represent the regulatory affairs function and provide regulatory guidance and strategy for our IVD and software products;
  • Plan, prepare and manage worldwide regulatory documents and submissions during development and life cycle management  of our products;
  • Act as regulatory contact person for competent authorities, external partners and in-house functions;
  • Conduct post market surveillance including complaint management;
  • Keep current with the regulatory and scientific environment and support the creation of standard operating procedures;
  • Support the quality management department in QM related tasks;
  • Supervise employees, giving work direction and training;
  • Report to the Head of Quality Management.
 
Qualifications:
  • Degree in chemistry, biology, pharmacy, medicine or related discipline or equivalent combination of education and experience;
  • At least two years’ experience as Regulatory Affairs Manager in an IVD/MD company including experiences with software as a medical device;
  • Detailed understanding of ISO 13485, ISO 14971, IVDD/MDD & MPG, 21 CFR, ISO 62304; FDA SW-guidance and other international in-vitro diagnostic device and medical device software regulations are required;
  • Experience in IVD regulatory submission for CE-Mark with Notified Body interactions;
  • Sound knowledge of QM requirements for medical devices (ISO, CFR, GMP) and software as a device (ISO 62304 und FDA SW-guidance);
  • Laboratory experience is a plus;
  • Organization and planning skills;
  • Project management, presentation, communication, negotiation and interpersonal skills.

Contact detail


How to apply:
Please send your CV, cover letter, academic transcript and testimonials by email to jobs@newoncology.de. Please indicate the job title in the header of your e-mail.
 
Send application to
Your contact is Sebastian Bartel, Head of Quality Management at NEO New Oncology GmbH.
 

Job profile


Working hours
Full-Time
Contract duration
Permanent
Type of job
Specialist
Work experience
jobexperience is required
Region
Germany (Nordrhein-Westfalen)
Working place
51105 Köln
Area of expertise
Healthcare & Public Health, Biology & Life Sciences, Chemistry, Pharmaceutics, Human medicine
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