Assistant Manager, Regulatory Affairs

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 lifes 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.

Assistant Manager Regulatory Affairs China

You will play a vital role in securing and maintaining regulatory approvals for our life-changing medical devices in the Chinese market. You are expected to excel in navigating complex regulatory pathways building strong relationships with authorities and ensuring full compliance with local return for your expertise strategic insight and dedication you will gain deep exposure to the entire lifecycle of Class III medical devices in one of the worlds most important markets contribute directly to bringing innovative therapies to patients in need and accelerate your career growth within a global regulatory team. This is your opportunity to shape the future of Cochlear implant accessibility in China while building a distinguished profile in the med-tech regulatory field.

You will be based in Shanghai reporting to the Director Regulatory Affairs International Markets.

More about the role:

In this role you will be the regulatory cornerstone for our operations in China. Your core mission is to ensure timely market access and sustained compliance for our advanced medical devices.

• End-to-End Regulatory Strategy & Submissions: Take ownership of devising submission strategies and preparing high-quality registration dossiers for NMPA approvals including Product Technical Requirement documents and managing all interactions with regulatory agencies.

• Regulatory Intelligence & Compliance: Proactively monitor interpret and communicate changes in Chinese regulations. Assess their impact on our portfolio and procedures and ensure ongoing compliance with all pre- and post-market requirements.

• Authority Relationship Management:Build and maintain strong collaborative relationships with the CMDE/NMPA local testing labs and other relevant authorities. Lead efforts to address government queries and support local type testing.

• Cross-functional Collaboration & Guidance: Serve as the key regulatory point of contact for China. Provide strategic regulatory guidance to R&D clinical and operations teams and conduct regulatory assessments for new products and changes.

• Process Improvement & Risk Management: Drive improvements in regulatory processes to enhance efficiency and quality. Anticipate regulatory risks and develop mitigation plans to support business timelines and successful product launches.

• Post-Market & Lifecycle Support: Manage regulatory aspects of product lifecycle including license renewals annual reports change notifications and support for post-market compliance activities and recall management when necessary.

More about you:

• Minimum 5 years of experience in regulatory affairs within the medical device sector with specific expertise in Class III device registration with the Chinese NMPA.
• Bachelors degree above.
• In-depth knowledge of China/Hainan regulatory requirements and proven experience in maintaining certifications for medical devices.
• Proven ability to demonstrate strong analytical problem-solving and organizational skills with exceptional attention to detail.
• Excellent communication negotiation and interpersonal skills with the ability to collaborate effectively in a local and international team environment.
• Proactive adaptable and comfortable working in a fast-paced ambiguous environment.
• Full professional proficiency in both Mandarin and English is essential.

More about what we offer:

As one of the worlds leading hearing care providers headquartered in Switzerland were 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.

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 candidates 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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