Regulatory Affairs Manager

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World's Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Position summary:
This position ensures rapid and timely approvals on product registrations' preparation and documentation. And the role supports Sr. Customer Excellence Manager for regulatory affairs and QMS to ensure compliance with governments requirements and Stryker policy.

Essential Duties & Responsibilities: (Detailed Description)
- Prioritize, plan, and review product registrations for NV product.
- Prepare, coordinate and submit regulatory applications to the local health authority.
- Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.
- Provide the leadership team with regular updates on product registration.
- Manage and educate China RA team to maintain good team performance.
- Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and workshop.
- Lobby with local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
- Support tender operations and hospital listing needs by timely supply of accurate regulatory documents.
- Establish relationships with local medical device industry groups and work with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.
- Establish and maintain a good working relationship with headquarters RA, R&D, QA etc. peers to gain positive & timely support for document preparation.
- Serve as regulatory consultant to marketing team and market access team.
- Serve as QA coordinator to ensure compliance with Stryker QMS documents and local policies.
Education & Experience:
• Bachelor degree in Science and Engineering or above.
• Relevant regulatory experiences in international company for more than 8 years.
• Good relationship with CMDE is preferred.
• Rich experiences in implantable and interventional medical devices.
• English can be used as a working language.
Physical & Mental Requirements:
• Well-organized and logical thinking
• Good at strategy making
• Detailed oriented
• Professional communication skills
• Patience and a great sense of responsibility

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.