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Regulatory Affairs Manager (m/w/d)

We are a successful, medium-sized company with an international focus, involved in the development, manufacturing, and marketing of high-quality medical devices.
To support our Regulatory Affairs department, we are looking for a Regulatory Affairs Manager (m/w/d)

Your Tasks

  • Maintaining the technical documentation according to MDR (EU 2017/745) requirements for class I/Is/IIb devices
  • Maintaining the clinical evaluation according to MDR requirements in collaboration with a consultant company
  • Maintaining the biological evaluation according to MDR in collaboration with a consulting company, coordinating necessary experiments with other departments and contract laboratories
  • Maintaining the MDR Post Market Surveillance system with trend analysis and writing the periodic safety update reports (PSUR), conception and evaluation of PMS-surveys
  • Supporting the creation, evaluation, and release of packaging materials and labeling of medical devices
  • Answering and processing regulatory customer inquiries and documents
  • Participating in initial certification, surveillance, and recertification audits by customers and the Notified Body, processing of deficiency reports from the Notified Body, and coordinating with the involved departments
  • Acting as an internal auditor for ISO 13485 and MDSAP requirements
  • Supporting R&D, manufacturing, and quality control in the development process of class III combination devices
  • Providing regulatory support in the process of supplier qualification for active pharmaceutical ingredients

Your Qualifications

  • Degree in natural sciences or comparable field of study
  • At least 5 years of experience in Regulatory Affairs with medical devices, pharmaceuticals, or combination devices
  • Having experience in composing the common technical dossier, especially modules 2 and 3 (Summary and CMC part) and eCTD sequences
  • Having experience in interacting with notified bodies, EU national competent authorities, the EMA, and the FDA regarding Premarket Submissions (Q-Subs), structured dialogs, and registration procedures
  • Fluent in German and English
  • A supportive and creative mentality to find innovative solutions for complex problems

What We Offer

The flexibility of a medium-sized company,
A competitive salary in the chemical tariff (IG BCE),
An unlimited employment contract,
An individual home-office arrangement after an intensive onboarding process (The position can be on-site or hybrid),
The possibility of bike leasing.

 

QUESTALPHA GmbH & Co. KG
Frau Gesa Klingelhöfer
Im Heerfeld 7, 35713 Eschenburg
Tel. +49 (0)-2774-705-868
E-Mail: career questalpha.com
Internet: www.questalpha.com