Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better.
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 Regulatory Affairs 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 team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
Develop and execute plans to get products registered for sales in China and to ensure product distribution and sales in China are in compliant with Chinese laws and regulations, as well as Stryker company’s rules and requirements
Essential Duties & Responsibilities: (Detailed Description)
- Prioritize, plan, and review product registrations for respective product lines
- 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 management team with regular updates on product registration.
- Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education
- 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 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 regional RA peers to gain positive & timely support for document preparation.
- Serve as regulatory consultant to marketing team and government regulatory agencies
Education & Experience:
- Bachelor degree in Medicine or Bioengineering or above preferred.
- Relevant regulatory and quality assurance experiences in international company for more than 2 years
Physical & Mental Requirements:
- Well-organized and logical thinking
- Good at planning and business processes,
- Detailed oriented
- Professional communication skills
- Patience and a great sense of responsibility
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com