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- Aufgaben: Lead quality and regulatory affairs, ensuring compliance and effective processes across EMEA.
- Arbeitgeber: Join Evident, a global leader in microscope systems with a strong presence in clinical diagnostics.
- Mitarbeitervorteile: Enjoy a dynamic work environment in Hamburg with opportunities for travel and professional growth.
- Warum dieser Job: Make a real impact in healthcare while leading a dedicated team in a collaborative culture.
- Gewünschte Qualifikationen: University degree required; experience in QMRA and knowledge of ISO standards essential.
- Andere Informationen: Fluency in English and German is a must; additional languages are a bonus.
Das voraussichtliche Gehalt liegt zwischen 72000 - 100000 € pro Jahr.
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Director Quality and Regulatory Affairs (f/m/d)
Headquartered in Tokyo, Japan, Evident employs around 4,500 people at a total of 57 locations worldwide. Evident Europe, headquartered in Hamburg, Germany, employs approximately 770 people in 16 countries. The product portfolio includes a wide range of microscope systems used in clinical diagnostics, medical and basic research, as well as in various industrial areas.
Responsibilities
- Support business units and functions in creation, implementation, and maintenance of processes and related documented information.
- Accountable for the effectiveness of the quality management system and corresponding certifications for the EMEA sales organisations.
- Responsible for regulatory compliance.
- Responsible for product registration in EMEA countries.
- In charge of the implementation of Field Safety Corrective Actions in the EMEA region.
- Ensure post market surveillance obligations are fulfilled according to the relevant regulations.
- Lead a team of 4.
- Must be based in the Hamburg office.
Requirements
- University degree or similar qualification.
- Experienced QMRA Lead.
- Proven knowledge of ISO 9001:2015 / ISO 13485:2016 and IVDR.
- Background knowledge of Laser and X-Ray regulations is ideal.
- Business-driven attitude.
- Excellent communication skills to effectively communicate across all levels of the EMEA organization and work productively with others in a team environment.
- Fluency in English and German; further language skills are a plus.
- Risk management knowledge is a plus.
- Must be based in Hamburg and willing to travel to other business locations on a constant basis (<25%).
Benefits
- Flexible working hours, including mobile work.
- 30 days of holiday time each year.
- 13.5 salaries a year.
- Regular training courses.
- Extensive company pension scheme.
- Payments towards an employee savings plan.
- Preventive healthcare, free beverages & fresh fruit and vegetables daily.
- Joint company events and activities.
- Interesting, diversified field of activity in an international working environment.
Evident Europe GmbH is an equal opportunities employer and we look forward to receiving your application.
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Director Quality and Regulatory Affairs (f/m/d) Arbeitgeber: Evident Group
Kontaktperson:
Evident Group HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Director Quality and Regulatory Affairs (f/m/d)
✨Tip Number 1
Fokussiere dich auf deine Führungskompetenzen. Da du ein Team von 4 Personen leiten wirst, ist es wichtig, dass du Beispiele für deine bisherigen Erfahrungen in der Teamführung und -entwicklung parat hast. Überlege dir, wie du in der Vergangenheit Herausforderungen gemeistert hast und welche Erfolge du erzielt hast.
✨Tip Number 2
Bereite dich darauf vor, über deine Kenntnisse in den relevanten Normen zu sprechen. Du solltest nicht nur mit ISO 9001:2015 und ISO 13485:2016 vertraut sein, sondern auch konkrete Beispiele nennen können, wie du diese Standards in der Praxis angewendet hast. Das zeigt dein tiefes Verständnis für Qualitätsmanagement.
✨Tip Number 3
Da die Position eine starke Kommunikationsfähigkeit erfordert, übe, wie du komplexe regulatorische Informationen klar und präzise vermitteln kannst. Überlege dir, wie du in der Vergangenheit erfolgreich mit verschiedenen Stakeholdern kommuniziert hast, um sicherzustellen, dass alle auf dem gleichen Stand sind.
✨Tip Number 4
Sei bereit, über deine Reisebereitschaft zu sprechen. Da die Rolle ständige Reisen zu anderen Standorten erfordert, solltest du deine Flexibilität und Bereitschaft, regelmäßig zu reisen, betonen. Das zeigt dein Engagement für die Position und die Unternehmensziele.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Director Quality and Regulatory Affairs (f/m/d)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Director Quality and Regulatory Affairs position. Understand the key responsibilities and requirements, especially regarding quality management systems and regulatory compliance.
Tailor Your CV: Customize your CV to highlight your experience in quality management and regulatory affairs. Emphasize your knowledge of ISO standards and any relevant certifications you hold. Make sure to include specific examples of your past achievements in these areas.
Craft a Compelling Cover Letter: Write a cover letter that connects your background to the specific needs of Evident. Discuss your leadership experience, communication skills, and how you can contribute to the effectiveness of their quality management system.
Highlight Language Proficiency: Since fluency in English and German is required, make sure to clearly state your language skills in both your CV and cover letter. If you have additional language skills, mention them as well, as they could be a valuable asset.
Wie du dich auf ein Vorstellungsgespräch bei Evident Group vorbereitest
✨Showcase Your Regulatory Expertise
Make sure to highlight your experience with ISO 9001:2015, ISO 13485:2016, and IVDR during the interview. Be prepared to discuss specific examples of how you've implemented these standards in previous roles.
✨Demonstrate Leadership Skills
As a Director, you'll be leading a team. Share your leadership philosophy and provide examples of how you've successfully managed teams in the past, especially in high-pressure situations.
✨Communicate Effectively
Since excellent communication skills are crucial for this role, practice articulating your thoughts clearly and concisely. Be ready to discuss how you would communicate complex regulatory information to various stakeholders.
✨Prepare for Questions on Compliance and Risk Management
Expect questions related to regulatory compliance and risk management. Brush up on relevant regulations and be ready to discuss how you would ensure compliance and manage risks in the EMEA region.
