Skip to main content

Für unseren Standort in Berlin-Schöneberg suchen wir baldmöglichst einen

Quality & Regulatory Manager (Vollzeit/full time) (m/f/d)

About the position:

  • Plan, implement and advance the company’s quality system according to ISO 13485, FDA QSR, ANVISA RDC 16/2013 and other international regulatory requirements specifically within the context of R&D processes
  • Promote the general understanding for and the acceptance of quality requirements within the company’s R&D group by devising and conducting regular trainings and workshops and coaching individual members of the group if needed
  • Set up and negotiate quality agreements with suppliers, customers, e.g.
  • Review R&D documents for QM compliance
  • Perform gap analyses on new or updated regulatory requirements and subsequently develop project plans for closing of any identified gaps specifically within the context of R&D processes
  • Create and regularly update key quality documents such as quality manual, SOPs etc.
  • Issue non-conformity reports, conduct root cause analyses and define and implement CAPAs
  • Take part in FMEAs and risk analyses according to ISO 14971
  • Assist in general communication with Notified Bodies, regulatory bodies, customers and suppliers and at audits
  • Lead and support quality management related projects, such as implementing new or updated regulatory requirements
  • Provide general assistance to the QM department as needed
  • Compile documentation for pre-market submission, perform company device registrations and stay on top of regulatory timelines


Qualifications:

  • Deep knowledge and understanding of key standards and regulations (ISO 13485, ISO 14971, IVDR)
  • Minimum of 5 years experience in all major aspects of quality management, preferably in the IVD industry and with a specific focus on R&D processes
  • Experience with regulatory research, device classification and regulatory strategy planning
  • Proficient in both German and English
  • Good writing skills


Nice-to-have:

  • Academic degree with research experience
  • Up-to-date formal training certifications in any of the above mentioned standards
  • Experience with MDSAP or other regulated markets beyond EU/US
  • Good level of German
     

If you feel addressed, please send us your informative short application with curriculum vitae and last reference, stating your salary expectations and the possible starting date by e-mail to:
careers@tib-molbiol.de

TIB Molbiol GmbH

Melbourne
Australia

T +61 43 811 9487
F
tib-molbiol@post.au

Read more

TIB Molbiol GmbH
Eresburgstraße 22-23
12103 Berlin
Germany

T +49 30 787 994 55
F +49 30 787 994 99
dna@tib-molbiol.de

Read more

TIB Molbiol S.r.l.
Largo Rosanna Benzi, no. 10
16132 Genova
Italy

T +39 010 362 8388
F +39 010 362 1938
dna@tibmolbiol.it

Read more

TIB Molbiol, LLC
PO Box 190
NJ 07710 Adelphia
USA

T +1 732 252 1110
F +1 732 252 1109
dna@tibmolbiol.com

Read more

TIB Molbiol S.A.S.
Carrera 100 # 5-169 Oficina 613 C
Santiago de Cali
Colombia

T +57 234 729 96
F
adn@tibmolbiol.com

Read more

TIB Molbiol SL
Calle Isabel Colbrand, 10 Nave 130
28050 Madrid
Spain

T +34 91 344 6642
F +34 91 344 6670
dna@tib-molbiol.es

Read more

Loading