Finde einen Job 
Finde eine Ausbildung 
Top Arbeitgeber 
Top Universitäten 
Für Unternehmen Auf einen Blick
- Aufgaben: Lead regulatory submissions for innovative medical devices and ensure compliance with EU and US regulations.
- Arbeitgeber: Join neuroloop, a pioneering company developing cutting-edge solutions for chronic disease treatment.
- Mitarbeitervorteile: Enjoy flexible hours, competitive pay, and a modern office in a vibrant city.
- Warum dieser Job: Be part of a dynamic team making a real impact in healthcare with exciting challenges.
- Gewünschte Qualifikationen: Degree in sciences or engineering with experience in medical device regulation required.
- Andere Informationen: Work in a supportive, family-owned environment with opportunities for personal growth.
Das voraussichtliche Gehalt liegt zwischen 60000 - 84000 € pro Jahr.
For neuroloop we are currently looking for a Senior Regulatory Affairs Manager (f/m/d).
neuroloop is a subsidiary of Aesculap AG, which was founded as a spin-off of the University of Freiburg and the Freiburg University Hospital. Based in Freiburg, we are developing a plat-form for the stimulation of the vagus nerve for the treatment of chronic diseases in connection with autonomous body functions. The core of our platform is a multichannel cuff electrode based on thin-film technology that allows us to selectively stimulate specific fibers in the nerve. Our first product, the baroloop stimulator, is specifically designed for the treatment of high blood pressure. Our main focus is to provide excellent clinical effectiveness while minimizing risks and side effects for the patient and a simple and safe use for the caregiver.
Duties and responsibilities
- You will prepare and compile regulatory submission dossiers for new medical device registrations and changes to existing products, in accordance with regulations
- The area of your responsibility comprises successful approval of medical devices (Class III) in the European and US market (MDR and FDA)
- You will monitor new legislations, policies, standards and guidelines that affect the assigned product portfolio.
- You will conduct post-market surveillance and report adverse events/field safety corrective actions to the authorities
- In your role you will be supporting currently marketed products, e.g, review engineering changes, product labeling and promotional materials
Professional competencies
- You have a degree in natural sciences, technology, engineering, medicine or a comparable degree or have acquired a comparable qualification
- You have several years of relevant professional experience in the field of medical device regulation
- You have extensive knowledge of regulatory affairs with a focus on international product approvals
- You have in-depth knowledge of European and international medical device regulations, directives and standards
- For communication in our international team your good skills in written and spoken German and English are required
Personal competencies
- Collaboration with cross-functional teams to collect necessary information is a daily mission for you
- You are enthusiastic about mastering challenges in a team and show the necessary stamina when things get difficult.
- You have a positive attitude and communicate in an open and direct manner
- You impress with your performance and achieve outstanding results
- You interact constructively, take responsibility and share your knowledge actively
What we offer
Become part of a corporate culture that fosters accountability, diversity and trust within a dynamic family-owned company. Work in a start-up environment with short lines of communication and quick decision-making, but with the opportunities and security of a global healthcare leader. Take over an exciting role in a company that is working to develop the next generation of active medical implants. You can expect a variety of tasks and challenges that will allow you to grow.
Benefits
- A family-friendly atmosphere with flexible working hours
- Performance-related remuneration.
- A brand new, modern office optimized for concentration and collaboration and generous social areas and creativity zones
- High quality life in one of Germany´s most attractive cities
#J-18808-Ljbffr
Senior Regulatory Affairs Manager (f/m/d) Arbeitgeber: Neuroloop GmbH
Kontaktperson:
Neuroloop GmbH HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Senior Regulatory Affairs Manager (f/m/d)
✨Tip Number 1
Familiarize yourself with the latest regulations and guidelines related to medical devices, especially MDR and FDA requirements. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs community, particularly those who have experience with Class III medical devices. Engaging in discussions or attending relevant conferences can provide insights and connections that may benefit your application.
✨Tip Number 3
Showcase your collaborative skills by preparing examples of how you've successfully worked with cross-functional teams in the past. Highlighting your ability to gather information and support product approvals will resonate well with our team-oriented culture.
✨Tip Number 4
Prepare to discuss specific challenges you've faced in regulatory affairs and how you overcame them. Your problem-solving abilities and positive attitude are key traits we value, so be ready to share your experiences.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Senior Regulatory Affairs Manager (f/m/d)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure you fully understand the responsibilities and requirements of the Senior Regulatory Affairs Manager position. Tailor your application to highlight your relevant experience in medical device regulation and your knowledge of MDR and FDA processes.
Highlight Relevant Experience: In your CV and cover letter, emphasize your professional experience in regulatory affairs, particularly with Class III medical devices. Provide specific examples of successful submissions or approvals you've managed.
Showcase Language Skills: Since good written and spoken German and English skills are required, make sure to demonstrate your proficiency in both languages. If applicable, include any certifications or experiences that validate your language skills.
Express Your Team Spirit: neuroloop values collaboration and a positive attitude. In your application, share examples of how you've successfully worked in cross-functional teams and how you handle challenges in a team setting.
Wie du dich auf ein Vorstellungsgespräch bei Neuroloop GmbH vorbereitest
✨Understand Regulatory Frameworks
Make sure you have a solid grasp of the European and US medical device regulations, especially MDR and FDA requirements. Be prepared to discuss how your experience aligns with these regulations and how you can contribute to successful product approvals.
✨Showcase Your Cross-Functional Collaboration Skills
Highlight your ability to work with diverse teams. Share specific examples of how you've collaborated with engineering, marketing, or clinical teams to gather necessary information for regulatory submissions.
✨Demonstrate Your Problem-Solving Attitude
Prepare to discuss challenges you've faced in previous roles and how you overcame them. Emphasize your positive attitude and stamina when dealing with complex regulatory issues.
✨Communicate Effectively in Both Languages
Since the role requires proficiency in both German and English, practice discussing your experiences in both languages. Be ready to switch between languages if needed during the interview to demonstrate your communication skills.
