Senior Regulatory Affairs Specialist - Medical - ASEAN
About Stryker 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
Who we want
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
What you will do
Basic purpose of role/Why the job exists:
The role is responsible for the registration maintenance of existing products and the management of regulatory submissions for new product registration for Stryker's Medical Division in the ASEAN region (Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam), whilst ensuring compliance with the relevant legislation, industry standards and Stryker policies.
Key areas of accountability:
- Manage independently all government product registrations/ change notifications/ re-registrations/ license renewals/ input requests-questions and other related actions to ensure timely initiation and closures per internal and regulatory deadlines to be in line with product launch/business plans. Prepare, submit and follow up consultations on applicable regulations on company products and processes. Support customers/ dealers/ partners in ASEAN likewise where Stryker entity is not the product holder, and ensure their timely registration/ license renewal success.
- Maintain regulatory trackers and manage the filing and record keeping of regulatory documentation.
- Thorough understanding of the legislation and medical device standards in Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam to ensure best business outcomes. Provide regulatory advice and expertise in projects including but not limited to acquisition integration, new product introduction, product lifecycle management.
- Identify and assess potential changes to relevant legislation and medical device standards within the ASEAN region and effectively communicate the impact to key stakeholders.
- Supporting Post Market Activity and ensuring timely and correct reporting/ follow up to authority.
- Assist the Medical team with ad hoc projects in alignment with Critical Success Factors.
What you need
Qualifications and experience required
- Minimum bachelor's degree in pharmacy, biomedical sciences or related
- Minimum 3-5 years experiences in ASEAN countries
- Communication, negotiation and co-ordination skills are required to liaise with internal and external colleagues and service providers
- Excellent planning and time management skills
- Ability to influence
- Be a team player, with excellent administration skills
- Regulation knowledge on medical devices
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.
Back to top