Regulatory Affairs Manager (m/f/d) EU & Europe / limited contract

Olympus; Hamburg; Hybrid; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

Une entreprise de premier plan dans le secteur médical recherche un Manager des Affaires Réglementaires basé à Hambourg. Ce rôle crucial implique une collaboration étroite avec divers départements pour garantir la conformité réglementaire et le lancement réussi de nouveaux produits. Le candidat idéal a au moins 5 ans d'expérience et des compétences en gestion de projets réglementaires, ainsi qu'une forte capacité de communication dans un environnement international. Des horaires flexibles et la possibilité de télétravail jusqu'à 60% sont également offerts.

Leistungen

30 jours de congés par an

Bureau moderne et inspirant

Restaurant d'entreprise avec cuisine vivante

Ticket de transport public 100% subventionné

Gym et groupes de sport en entreprise

Programme d'assistance aux employés

Plan de retraite d'entreprise

Offres de soins médicaux et de vaccinations

Garde d'enfants par un partenaire

Location de vélos

Qualifikationen

• Minimum 5 ans en affaires réglementaires avec expérience en gestion.
• Compétences en gestion des soumissions réglementaires.
• Excellentes compétences interpersonnelles.

Aufgaben

• Point de contact principal pour les exigences réglementaires.
• Supporter l'enregistrement des produits dans l'UE.
• Assurer la conformité avec les exigences réglementaires de l'UE.

Kenntnisse

Gestion de projet réglementaire

Communication écrite et verbale

Collaboration interfonctionnelle

Compétences informatiques

Ausbildung

Diplôme en affaires réglementaires ou comparable

Tools

MS Office

Systèmes de gestion réglementaire (RIM, PLM)

Plateformes QMS

Jobbeschreibung

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Regulatory Affairs Manager (m/f/d) EU & Europe / limited contract, Hamburg

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Client:

Olympus

Location:

Hamburg, Germany

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

d92fa2c9f867

Job Views:

4

Posted:

23.06.2025

Expiry Date:

07.08.2025

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Job Description:

- Serve as primary point of contact for regulatory requirements for the market access in the EU and EFTA
- Support the registration of products across the EU, EFTA, and Europe
- Act as regulatory advisor during new product launches
- Conduct regulatory assessments for product launches
- Ensure compliance with applicable EU regulatory requirements
- Execute regulatory related projects within the EMEA region
- Close collaboration with relevant internal stakeholders such as R&D, Manufacturing, Supply Chain, and Quality - both regionally and globally
- Manage Quality Management System (QMS) processes and tools

- Minimum of 5 years of experience in Regulatory Affairs, including leadership or management experience, ideally within a matrix organization
- Proven experience in regulatory project management support
- Experience in authoring and/or managing regulatory submissions (e.g., CE Mark, international)
- Ability to prepare regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File, international)
- Experience in managing and operating QMS processes and systems
- Understanding of global process flows and cross-functional collaboration
- Strong interpersonal skills with the ability to manage effective working relationships within Regulatory Affairs and with other departments (R&D, Manufacturing, Supply Chain, Quality, etc.)
- Excellent written and verbal communication skills in a multicultural and international environment
- Strong IT skills
- Strong IT proficiency, including experience with regulatory systems (e.g., RIM, PLM), QMS platforms, and standard MS Office applications (Excel, Word, etc.)

-Flexible working hours, remote work possible (up to 60%)
- 30 days of holidays per year
- Modern office and an inspiring working environment
- Employee restaurant with live cooking and healthy food (subsidized)
- Public transport ticket (100 % subsidized) or free parking space
- Company sport groups and an inhouse company gym
- Employee Assistance Program to support your health, mental and emotional well-being
- A comprehensive company pension scheme
- Company medical officer and vaccination offers
- Childcare through our ‘Buttje&Deern’ partner
- Bike leasing