Auf einen Blick
- Aufgaben: Manage regulatory approvals for Advanced Bionics products across multiple regions.
- Arbeitgeber: Join Sonova, a leader in innovative hearing care solutions that improve lives.
- Mitarbeitervorteile: Enjoy flexible working hours, remote work options, and 30 days of annual leave.
- Warum dieser Job: Make a real impact on people's lives while growing in a supportive team environment.
- GewĂĽnschte Qualifikationen: 5+ years in regulatory affairs with a background in medical devices required.
- Andere Informationen: Opportunity to work in a fast-growing industry with a focus on personal development.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
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You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s unforgettable moments.
We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.
If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you.
Join Sonova. Create sense.
Stuttgart-Fellbach, Germany
Senior Specialist Regulatory Affairs
156124
We are looking for a European regulatory affairs team member responsible for managing pre-market and post-market regulatory approvals and activities for Advanced Bionics products in the EU & EFTA region, UK, the Balkan States, Ukraine, South Africa, Turkey, and Russia.
You will prepare, assist and manage regulatory submissions for assigned countries and provide regulatory support in system implementation projects, post-market, and labeling compliance.
Furthermore, you will support as deputy “Person Responsible for Regulatory Compliance” for European Authorized Representative (PRRC-AR). Remote Work within Germany is possible.
- Sonova and our brands offer very good perspectives and career opportunities
- Permanent contract and atmosphere of mutual trust in a highly motivated team
- Flexible working times, JobRad, attractive pay according to achievement, 30 days annual holiday
- Modern work environment and equipment
- You help to improve the quality of life of millions of people with hearing loss
- Training and development opportunities – we believe every employee deserves a development plan. Come, learn, and grow with us!
Main tasks and responsibilities:
- Support compliance with European Medical Device Regulation and relevant other regulations (e.g., Battery regulation, AI, Telecom etc.) in the EU & EFTA region.
- Country management: ensure local country compliance for EU, UK, the Balkan States, Ukraine, Turkey, and Russia requirements for Class III implantable medical devices and accessories.
- Help to ensure regulatory approvals and relevant changes are achieved and maintained in accordance with business plan, as well as anticipating regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory / related teams.
- Help in communication and preparation of relevant documentation to the Notified Body and National Competent Authorities plus assistance in audits by external bodies.
- Support colleagues to ensure that they are fulfilling requirements associated with Class III implantable medical devices in the countries for which responsibility is taken and maintenance of international registrations/certifications throughout the product lifecycle.
- Provide regulatory input to new product development, regulatory change assessments to Sustaining Engineering, and to project teams/RA country managers.
Your profile:
- Apprenticeship in a medical field, Bachelor degree in Engineering, Biology or Medical, ideally with further education in Regulatory Affairs (e.g., RAPS, TĂśV SĂĽd Academy).
- Developed knowledge in the medical device field, 5+ years experience of working in the medical device field in the regulatory affairs department.
- Strong writing and data management skills and basic understanding of Class III medical device labeling requirements.
- Willingness to travel up to 20%.
- IT skills: Microsoft Office, ideally knowledge of some statistics software.
In return, we offer an exciting and challenging position with great potential for personal development, with a unique organization in a fascinating and fast-growing medical industry. If you want to work in an enthusiastic, motivated team and help launch the hearing implants of the future then send us your online application in English. We favour disabled applicants over non-disabled applicants if they have the same qualification.
For this vacancy only direct applications will be considered.
Create impact. Transform lives – sonova.com/careers
Sonova is an equal opportunity employer
We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the marketplace. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.
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Senior Specialist Regulatory Affairs (m/f/d) Arbeitgeber: Sonova Group
Kontaktperson:
Sonova Group HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Senior Specialist Regulatory Affairs (m/f/d)
✨Tip Number 1
Familiarize yourself with the European Medical Device Regulation and other relevant regulations. Understanding these frameworks will not only help you in interviews but also demonstrate your commitment to compliance and regulatory excellence.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with Class III medical devices. Engaging with industry experts can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and changes in medical device regulations. This knowledge will be crucial during discussions with the hiring team and will show that you are proactive about your professional development.
✨Tip Number 4
Prepare to discuss specific examples from your past experience where you successfully navigated regulatory challenges. Highlighting your problem-solving skills and ability to work collaboratively will resonate well with the team at Sonova.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Senior Specialist Regulatory Affairs (m/f/d)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Specialist Regulatory Affairs position. Understand the key responsibilities and required qualifications, as this will help you tailor your application effectively.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 5+ years of experience in regulatory affairs within the medical device field. Provide specific examples of how you've managed regulatory submissions and compliance with relevant regulations.
Showcase Your Skills: Demonstrate your strong writing and data management skills in your application. Mention any experience with Class III medical device labeling requirements and your proficiency in Microsoft Office and any statistics software.
Craft a Compelling Cover Letter: Write a personalized cover letter that reflects your passion for improving the quality of life for individuals with hearing loss. Explain why you want to work at Sonova and how your background aligns with their mission and values.
Wie du dich auf ein Vorstellungsgespräch bei Sonova Group vorbereitest
✨Show Your Passion for Regulatory Affairs
Make sure to express your enthusiasm for regulatory affairs and how it impacts the medical device industry. Share specific examples of how your work has contributed to compliance and innovation in previous roles.
✨Demonstrate Your Knowledge of Regulations
Be prepared to discuss your understanding of European Medical Device Regulation and other relevant regulations. Highlight any experience you have with Class III medical devices and how you've navigated regulatory challenges in the past.
✨Highlight Your Team Collaboration Skills
Since teamwork is emphasized, share examples of how you've successfully collaborated with cross-functional teams. Discuss how you’ve supported colleagues in meeting regulatory requirements and how you can contribute to a motivated team environment.
✨Prepare for Questions on Problem-Solving
Expect questions about how you handle regulatory obstacles and emerging issues. Prepare to discuss specific situations where you anticipated challenges and developed effective solutions, showcasing your proactive approach.