Regulatory Affairs Manager (m/w/d)
05.12.2024
QUESTALPHA GmbH&Co.KG
Eschenburg (DE)
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Regulatory Affairs Manager (m/w/d)
QUESTALPHA GmbH&Co.KG
Eschenburg (DE)
Aktualität: 05.12.2024
Anzeigeninhalt:
05.12.2024, QUESTALPHA GmbH&Co.KG
Eschenburg (DE)
Regulatory Affairs Manager (m/w/d)
Über uns:
We are a successful, medium-sized company with an international focus, involved in the development, manufacturing, and marketing of high-quality medical devices.
Aufgaben:
- 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
Qualifikationen:
- 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
Wir bieten:
- 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 and other benefits
Unser Kontakt:
QUESTALPHA GmbH & Co. KG
For the attention of Mrs. Gesa Klingelhöfer
Im Heerfeld 7, 35713 Eschenburg, Tel. +49 (0) 2774 705 868
E-Mail: career@questalpha.com
Www.questalpha.com
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