Regulatory Affairs / Quality Manager (m/f/d)

Job: Regulatory Affairs / Quality Manager (m/f/d)

SternMed GmbH is a manufacturer of medical technology products in Baden-Württemberg near the border triangle. Our company enjoys a reputation as an innovative manufacturer of imaging systems, OR solutions and patient care systems. We represent intelligent and high quality, yet affordable solutions, which we market worldwide through our international distribution partners.

Your tasks

  • Planning, coordination and execution of registrations for medical devices class I-IIb nationally as well as internationally
  • Implementation of the Medical Device Regulation (MDR)
  • Preparation and maintenance of registration documentation for submission to notified bodies according to MDR in cooperation with other departments
  • Administration of approvals and registrations on European level (e.g. EUDAMED)
  • Communication with authorities & notified bodies
  • Accompaniment of audits by authorities, notified body and customers

Your profile

  • Completed scientific / technical studies, preferably with a focus on Regulatory Affairs, or comparable qualification
  • Professional experience in the area of Quality & Regulatory Affairs in the field of medical technology
  • Knowledge regarding product approvals of medical devices as well as knowledge of regulatory requirements (MDR, ISO 13485, 60601-1 ff)
  • Basic knowledge of clinical evaluation according to MDR and MEDDEV 2.7/1 rev.4 is desirable
  • Confident appearance in global acting structures, strong communication skills, independent and structured way of working
  • Fluent in written and spoken German and English
  • Good knowledge of the common MS Office products

We offer

A pleasant working environment on a technically high standard, which is characterized by the diversity of our employees, competences and approaches. We stand for a good working atmosphere, an open and appreciative corporate culture with flat hierarchies and personal responsibility. In addition, we offer various benefits (such as personal development and training opportunities) as well as attractive remuneration / permanent employment in a growing owner-managed company and much more.

SEI Group with a start-up atmosphere offers you the opportunity to join our passionate, multicultural team. We welcome you to a growth-oriented group of companies with open doors and short decision-making paths.

Candidates for this position must be legally authorized to work in Germany. Visa sponsorship is currently not available. We thank you for your understanding.

Have we aroused your interest? Then we are looking forward to receiving your application including your starting date and salary expectations!

Please send your application via the link below or to this email address:

SternMed GmbH
Schubertstr. 31
88214 Ravensburg

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