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Stryker

Senior Regulatory Affairs Specialist - Medical - ASEAN

Singapore

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.

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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.

Job ID: Stryker_Combined-93PXmPHUj6vJ
Employment Type: Other

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • FSA With Employer Contribution
    • HSA
    • HSA With Employer Contribution
    • On-Site Gym
    • Mental Health Benefits
    • Virtual Fitness Classes
  • Parental Benefits

    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
    • On-site/Nearby Childcare
  • Work Flexibility

    • Flexible Work Hours
    • Remote Work Opportunities
    • Hybrid Work Opportunities
    • Work-From-Home Stipend
  • Office Life and Perks

    • Casual Dress
    • Happy Hours
    • Company Outings
    • Commuter Benefits Program
    • Snacks
    • Some Meals Provided
    • On-Site Cafeteria
    • Holiday Events
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Personal/Sick Days
    • Sabbatical
    • Leave of Absence
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Company Equity
    • Stock Purchase Program
    • Performance Bonus
    • Relocation Assistance
    • 401(K)
    • Financial Counseling
  • Professional Development

    • Tuition Reimbursement
    • Learning and Development Stipend
    • Promote From Within
    • Mentor Program
    • Shadowing Opportunities
    • Access to Online Courses
    • Lunch and Learns
    • Internship Program
    • Work Visa Sponsorship
    • Leadership Training Program
    • Associate or Rotational Training Program
  • Diversity and Inclusion

    • Diversity, Equity, and Inclusion Program
    • Employee Resource Groups (ERG)

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