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- Aufgaben: Manage regulatory documentation and ensure compliance with MDR for medical devices.
- Arbeitgeber: Join a successful, international company specializing in high-quality medical devices.
- Mitarbeitervorteile: Enjoy flexible work arrangements, competitive salary, and bike leasing options.
- Warum dieser Job: Be part of a creative team solving complex problems in a supportive environment.
- Gewünschte Qualifikationen: Degree in natural sciences and 5+ years in Regulatory Affairs required.
- Andere Informationen: Position can be on-site or hybrid after onboarding.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
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:
Internet:
#J-18808-Ljbffr
REGULATORY AFFAIRS MANAGER (M/W/D) Arbeitgeber: Questalpha GmbH & Co. KG
Kontaktperson:
Questalpha GmbH & Co. KG HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: REGULATORY AFFAIRS MANAGER (M/W/D)
✨Tip Number 1
Nutze dein Netzwerk! Sprich mit ehemaligen Kollegen oder Kontakten aus der Branche, die bereits in der Regulatory Affairs arbeiten. Sie können dir wertvolle Einblicke geben und möglicherweise sogar Empfehlungen aussprechen.
✨Tip Number 2
Halte dich über aktuelle Entwicklungen in der Regulierung von Medizinprodukten auf dem Laufenden. Abonniere relevante Fachzeitschriften oder Online-Plattformen, um immer informiert zu sein und deine Kenntnisse zu erweitern.
✨Tip Number 3
Bereite dich auf mögliche Interviews vor, indem du typische Fragen zu MDR-Anforderungen und Erfahrungen mit Notified Bodies durchgehst. Überlege dir konkrete Beispiele aus deiner bisherigen Berufserfahrung, die deine Fähigkeiten unter Beweis stellen.
✨Tip Number 4
Zeige deine Problemlösungsfähigkeiten! Bereite dich darauf vor, innovative Ansätze zu präsentieren, die du in der Vergangenheit zur Lösung komplexer Probleme im Bereich Regulatory Affairs entwickelt hast.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: REGULATORY AFFAIRS MANAGER (M/W/D)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory Affairs Manager position. Understand the key responsibilities and requirements, especially regarding MDR compliance and interaction with regulatory bodies.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in Regulatory Affairs, particularly with medical devices. Mention specific projects or tasks that align with the responsibilities listed in the job description.
Showcase Language Proficiency: Since fluency in German and English is required, ensure that your application reflects your language skills. If applicable, include any certifications or experiences that demonstrate your proficiency.
Tailor Your Application: Customize your cover letter to reflect your understanding of the company's needs and how your background makes you a suitable candidate. Use specific examples to illustrate your problem-solving abilities and innovative mindset.
Wie du dich auf ein Vorstellungsgespräch bei Questalpha GmbH & Co. KG vorbereitest
✨Understand MDR Requirements
Make sure you have a solid grasp of the Medical Device Regulation (MDR) requirements, especially for class I/Is/IIb devices. Be prepared to discuss how your experience aligns with maintaining technical documentation and clinical evaluations according to these regulations.
✨Showcase Your Regulatory Experience
Highlight your past experiences in Regulatory Affairs, particularly your interactions with notified bodies and national competent authorities. Be ready to provide specific examples of how you've handled premarket submissions and audits.
✨Demonstrate Problem-Solving Skills
The company values a supportive and creative mentality. Prepare to discuss instances where you've found innovative solutions to complex regulatory challenges, showcasing your ability to think critically and adapt.
✨Prepare for Language Proficiency
Since fluency in both German and English is required, be ready to demonstrate your language skills during the interview. Practice discussing your regulatory experiences in both languages to show your comfort level.
