Senior Regulatory Affairs Manager (APAC ex. China)

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 senseby bringing sound to life. Our innovative hearing care solutions help millionsof people enjoy life’s unforgettable moments.

Weoffer 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.

Senior Regulatory Affairs Manager (APAC ex. China)

The Senior Manager of Regional Regulatory Affairs for APAC (excluding China) is responsible for leading and developing the regional regulatory affairs structure to support market access and lifecycle compliance across APAC countries.

The role serves as the primary liaison between local RA representatives in Group Companies (GCs) regional stakeholders, global RA functions and other global stakeholders, ensuring alignment, communication of regional requirements, and integration into global regulatory processes.

The position focuses on regional coordination, capability building, and regulatory oversight for medical device in hearing industry including implantable devices.

More about the role:

•         Lead and further develop the regional RA structure in APAC (excluding China) to ensure adequate regulatory support for current and future business needs.

•         Build, structure, and strengthen the APAC RA team capability, ensuring appropriate coverage of key markets and regulatory requirements.

•         Act as the main interface between APAC RA representatives in GCs and global RA functions (e.g RA Development, International RA Coordination, and other central teams) and Launch PM and regional commercial teams.

•         Collect, consolidate, and communicate local regulatory requirements, market access needs, and regulatory updates from APAC regions to regional and global stakeholders.

•         Ensure alignment between regional regulatory activities and global product development, certification, and lifecycle processes.

•         Support harmonization of regulatory approaches across APAC markets where applicable.

•         Facilitate communication of global regulatory updates to regional RA teams.

•         Oversee regional readiness for product launches, registrations, renewals, and regulatory changes.

•         Monitor relevant regulatory developments across APAC (excluding China) and assess potential impact.

•         Support commercial strategies by providing regulatory input for OTC and online sales channels, including compliance with OTC requirements, direct-to-consumer (DTC) risk management, e-commerce labeling obligations, and post-market vigilance requirements.

•         Support coordination of audits, authority interactions, and compliance topics within the region as needed.

More about you:  

Education

• Basic Education: University degree in Life Sciences, Engineering, Regulatory Affairs, or related technical field.
• Further Education: Advanced qualification in Regulatory Affairs, Quality Management, or related discipline (preferred).
• Continuous Development: Continuous professional development in regional regulatory frameworks.

Work Experience

• Several years of experience in Regulatory Affairs within the medical device or regulated industry.
• Experience with multi-country regulatory environments in APAC.
• Experience in leadership roles and/or regional coordination.
• Experience interacting with regulatory authorities and internal global functions.

Personal Competencies

• Strategic and structured thinking.
• Strong organizational and prioritization skills.
• High-level of accountability and compliance orientation.
• Ability to manage complexity across multiple markets.

Social Competencies

• Strong communication and stakeholder management skills.
• Ability to collaborate effectively with regional RA teams in Group Companies and global functions.
• Diplomatic and culturally aware communication style.
• Service-and solution-oriented mindset.

Leadership Competencies

• Experience building, developing, and structuring regional teams.
• Ability to provide guidance in a matrix organization.
• Capability to align regional needs with global processes.
• Ability to drive performance and capability development across countries.
• Be a curious learner, persevere to win, embrace and lead change, and prioritize and focus.

Professional Competencies

• Strong understanding of regulatory requirements in APAC markets (excluding China).
• Experience in regulatory lifecycle management and market access coordination.
• Knowledge of regulatory documentation, compliance processes, and audit readiness.
• Ability to consolidate regional regulatory requirements and communicate them to global teams.

Skills& Languages

• Languages: English Fluent; Additional APAC languages (advantageous depending on markets covered).
• IT Skills: Proficiency in MS Office; Experience with regulatory tracking or project management tools.

More about what we offer:

As one of the world’s leading hearing care providers headquartered in Switzerland, we ’re committed to building an inclusive culture. We want to create an environment where you can balance a successful career with your commitments and interests outside of work, through our flexible hybrid working model. We offer a wide range of training opportunities for both your professional and personal development, and there are exceptional growth opportunities with individual development plans.

Interested candidates, please submit your updated resume with your current and expected remuneration to [email protected], Talent Acquisition Manager.

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.