Regulatory Affairs Manager

Job content

Who we are

In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we – through our core business brands Phonak, Unitron, Hansaton, Advanced Bionics and AudioNova – develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.

You support the Regulatory Affairs Team in the building of documentation dossiers to achieve timely regulatory approvals and maintenance of the existing portfolio.

Your tasks

• Lead US regulatory submissions including pre-submission, pre-submission issue meeting and leading all 510(k) relevant activity to achieve timely US market clearance
• Prepare US market access regulatory strategy; requiring familiarity with all FDA relevant regulatory approval / clearance mechanisms
• Preparation, review and release of EU MDR technical documentation to achieve timely regulatory approvals and maintenance of existing portfolio
• Review and release of product relevant documentation conforming to MDR, RF, MDSAP requirements
• Key contact and support for distributors and affiliates for global submission efforts
• Work closely with product development, marketing and other teams ensuring strategy falls in line with regulatory guidelines / requirements through the product life-cycle
• Update regulatory knowledge to include new industry developments and ensure the implementation into product development strategy, design, manufacturing and life-cycle efforts
• Support regulatory strategies for global markets
• Ensure regulatory approvals are achieved and maintained in a timely fashion
• Shares best practice involving International regulatory submissions
• Work to implement processes, standards and training that ensure a continuous regulatory compliance and a constant status of “inspection readiness”
• Support auditing teams and QA team when necessary

Your profile

• Bachelor degree in a scientific discipline and/or further education in engineering or life sciences with demonstrated experience within regulatory affairs
• At least 8 years exposure in a regulatory affairs position in medical device area
• Experience of leading regulatory affairs submissions
• Strong understanding of international regulatory landscape & required approaches (e.g. USA FDA, Canada, EU)
• Solution-driven person who likes to work independently
• Effective communication and interpersonal skills with sense of responsibility
• Team player and enthusiastic individual with drive
• Fluent in English, German is an advantage

Our offer

We can offer you a new challenge, with interesting tasks and much more - including an open corporate culture, flat hierarchies, support for further training and development, opportunities to take on responsibility, an excellent range of foods, sports and cultural facilities, attractive employment conditions, and flexible working time models in various roles.

Daryl Alther, Talent Acquisition Manager, is looking forward to receiving your complete application (CV, references and certificates) via our online job application platform.

For this vacancy only direct applications will be considered.

Sonova AG

Laubisrütistrasse 28

CH-8712 Stäfa

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 market place. 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.