Regulatory Affairs Manager

vor 5 Monaten

Zurich, Schweiz Sonova Vollzeit

Who we are

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.
- Staefa, SwitzerlandRegulatory Affairs Manager
- As Regulatory Affairs Manager you are part of the RA team responsible for providing regulatory support and guidance to project teams. You will also be involved early in project development to align on the regulatory strategy and launch planning. You will be responsible for the review of relevant project deliverables, for the monitoring of new and changing regulatory requirements and standards, and for the management of activities and milestones to achieve compliance with changed standards and regulations. You will support with post-market surveillance and vigilance reporting, and directly report to the Director Regulatory Affairs.**Your tasks**
- Preparation of documentation dossiers to achieve timely regulatory approvals and maintenance of the existing portfolio
- Establish and maintain a systematic process of collecting, analyzing, and disseminating information about regulatory requirements, policies, and guidelines that affect the development, manufacturing, distribution and surveillance, and regulation of Sonova medical devices and accessories
- Keep abreast of new or changed regulations, guidance documents, and consensus standards in the target markets/regions and communicate relevant changes to the appropriate internal stakeholders
- Work with Legal to ensure compliance with new legal texts in line with effective dates and transition periods
- Review and release of product relevant documentation
- Work closely with product development, marketing, and other teams ensuring strategy falls in line with Regulatory guidelines/requirements through the whole product life-cycle
- Provide guidance on the approval process through EU, MDSAP, and other markets for medical devices and their accessories
- Support post market surveillance activities including process development, planning, scheduling, and timely reporting according to MDR and applicable international requirements
- Update Regulatory knowledge with any new developments within the industry and ensure the implementation into product development strategy, design, manufacturing, and life-cycle efforts
- Support auditing teams, QA team, and team leader when necessary

**Your profile**
- Bachelor's / Master's Degree or equivalent in a technical or scientific field (e.g. Biochemistry, Biomedical, Electrical, or Chemical Engineering), ideally with further education in Engineering, Life Sciences, or Regulatory Affairs
- At least 3-4 years of professional experience in a Regulatory Affairs position in a Medical Device area
- Strong understanding of International regulatory landscape and required approaches/strategies (e.g. USA FDA, Canada, EU)
- Experience of leading Regulatory Affairs submissions
- Experience with monitoring standards and regulation compliance
- Analytical thinking and solution-oriented; driven, enthusiastic, and keen on progressing skills
- Open-minded, objective, trustworthy and reliable teamplayer with excellent communication and interpersonal skills and good work ethics
- Ability to manage time effectively and independently by prioritizing among multiple projects, tasks, and duties
- Fluency in English, both written and spoken
- Excellent MS-Office skills

**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. Employment level 80-100%.- Sonova AG
- Laubisrütistrasse 28
- CH-8712 Stäfa
- +41 58 928 01 01Sonova is an equal opportunity employer.

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