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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Regulatory Affairs within the medical device industry, with a strong focus on developing regulatory strategies and managing global teams. Proven ability to collaborate across functions and mentor staff while navigating complex regulatory environments in APAC countries.
Highest-signal resume keywords
Regulatory Affairs ExperienceMedical Device Industry KnowledgeTeam Management SkillsRegulatory Strategy DevelopmentStakeholder Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Strategy DevelopmentRegulatory SubmissionsHealth Authority InteractionsProduct Lifecycle ManagementRegulatory Compliance
Soft Skills
Excellent Communication SkillsMentoring and LeadershipDetail OrientedDecision Making
Industry Keywords
Medical DeviceDental SolutionsHealthcareAPAC Regulatory ExperienceGlobal Team Management
About the role
Key responsibilities & impact- Develop and execute regulatory strategies to achieve product approvals faster than competitors
- Direct complex decision making among stakeholders and senior leaders in complex and evolving regulatory areas
- Advise and guide regulatory strategy development, Health Authority interactions, and submission activities for Medical Surgical and Dental Solutions product portfolios
- Collaborate with R&D, Quality Assurance, and Clinical Affairs to integrate regulatory requirements into product development and lifecycle management
- Participate in business and functional strategic leadership meetings and forums representing regulatory affairs perspective
- Mentor and guide regulatory staff and teams across all product modalities
- Establish team goals and objectives aligned with business and regional strategies
- Build collaborative relationships with stakeholders, senior leadership, external partners, and contract organizations
- Lead and develop a high-performing regulatory organization
Requirements
What you’ll need- Bachelor's degree or higher in a Science or Engineering discipline
- Master's degree in science or engineering discipline
- Ten (10) or more years of Regulatory Affairs experience in the medical device industry
- Previous Dental, Medical Device, or Healthcare experience
- Ability to manage, direct, and develop a global team located in multiple countries
- Excellent verbal and written communication skills in English
- Deep regulatory experience across multiple APAC countries
- Detail oriented with the ability to navigate a complex matrix environment
- Must reside in an APAC country, preferably Singapore
- Must be legally authorized to work in country of employment without sponsorship for employment visa status
Benefits
Comp & perks- Competitive pay and benefits
- Programs supporting physical and financial well-being
