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).

Responsibilities:

• 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.

Minimum Requirements:

• 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.
• Experience in composing the common technical dossier, especially modules 2 and 3 (Summary and CMC part) and eCTD sequences.
• 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