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- Aufgaben: Support the Imaging product line by managing regulatory documentation and compliance.
- Arbeitgeber: Join a leading company in medical devices focused on innovation and quality.
- Mitarbeitervorteile: Enjoy flexible hours, 30 vacation days, training opportunities, and corporate perks.
- Warum dieser Job: Be part of a dynamic team impacting global healthcare with your expertise.
- GewĂĽnschte Qualifikationen: Requires scientific studies, experience in regulatory affairs, and strong communication skills.
- Andere Informationen: Opportunities for professional development and various childcare options available.
Das voraussichtliche Gehalt liegt zwischen 48000 - 72000 € pro Jahr.
Your Mission
- You support the “Imaging” product line throughout its entire lifecycle.
- Coordinating and creating technical documentation for the assigned medical device groups is part of your responsibilities.
- You identify global regulatory requirements for the assigned medical device groups.
- Developing testing and approval strategies for global distribution is one of your tasks.
- You continuously analyze and optimize processes.
- Monitoring regulatory compliance throughout the entire product lifecycle is part of your role.
- You work closely with development teams from other departments and ensure that they receive targeted training on regulatory requirements.
Your Talents
- Completed scientific or technical studies.
- Several years of professional experience in the field of regulatory affairs for active medical devices.
- Knowledge of the relevant product standards.
- Expertise in the field of medical devices, especially in the area of endoscopy/imaging and electrical safety is desirable.
- Confident manner in international project structures.
- Strong communication skills and independent working style.
- Very good knowledge of German and English.
Your Benefits
- Flexible working hours & mobile working: In many areas, working hours and location can be arranged as required.
- 30 vacation days and various special payments.
- Further training opportunities: Open in-house seminar program, extensive e-learning offering, professional development courses and much more.
- Corporate benefits and bicycle leasing.
- Subsidy for private pension plan and company health management.
- Various childcare options – at the headquarters in Tuttlingen.
- Health, sports, cultural and leisure activities – offers vary depending on location.
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Regulatory Affairs Manager (m/f/d) Arbeitgeber: KARL STORZ
Kontaktperson:
KARL STORZ HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Regulatory Affairs Manager (m/f/d)
✨Tip Number 1
Familiarize yourself with the specific regulatory requirements for medical devices, especially in the imaging and endoscopy sectors. This knowledge will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, particularly those who have experience with active medical devices. Engaging in discussions or attending relevant conferences can provide insights and connections that may benefit your application.
✨Tip Number 3
Showcase your ability to work independently and communicate effectively in both German and English. Prepare examples from your past experiences where you successfully navigated international project structures or trained teams on regulatory compliance.
✨Tip Number 4
Highlight any experience you have with process optimization in regulatory affairs. Be ready to discuss specific strategies you've implemented in previous roles that improved compliance or efficiency, as this aligns closely with the responsibilities of the position.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Regulatory Affairs Manager (m/f/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 required skills, especially in regulatory compliance and technical documentation.
Highlight Relevant Experience: In your CV and cover letter, emphasize your professional experience in regulatory affairs, particularly with active medical devices. Mention any specific projects or achievements that demonstrate your expertise in endoscopy/imaging and electrical safety.
Showcase Communication Skills: Since strong communication skills are essential for this role, provide examples of how you've effectively communicated with cross-functional teams or trained colleagues on regulatory requirements in your application.
Tailor Your Application: Customize your CV and cover letter to reflect the language and requirements mentioned in the job description. Use keywords related to regulatory affairs and medical devices to ensure your application stands out.
Wie du dich auf ein Vorstellungsgespräch bei KARL STORZ vorbereitest
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of global regulatory requirements, especially those related to active medical devices. Be prepared to discuss specific standards and regulations that are relevant to the imaging product line.
✨Demonstrate Your Communication Skills
Since strong communication skills are essential for this role, practice articulating your thoughts clearly. Be ready to explain complex regulatory concepts in a way that is easy to understand, as you will need to train development teams.
✨Prepare for Process Optimization Questions
Expect questions about how you have previously analyzed and optimized processes in regulatory affairs. Have examples ready that demonstrate your ability to improve efficiency while ensuring compliance.
✨Familiarize Yourself with the Company’s Products
Research the company’s imaging product line and any recent developments in the field of endoscopy/imaging. Showing that you are knowledgeable about their products will demonstrate your genuine interest in the position.
