Sr Regulatory Affairs Specialist
Masimo is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategies and submissions for JPAC market expansion. The role involves managing tender readiness, interacting with regional health authorities, and ensuring compliance across product lifecycles. Candidates must have 3-5 years of experience in the medical device industry with specific expertise in APAC regulatory frameworks. The position requires strong cross-functional collaboration with clinical and commercial teams to drive business objectives.
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Experience
3-5 years
Function
Research
Work mode
Onsite, India
Company
Tier 2
What you will work on
Masimo is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategies and submissions for JPAC market expansion. The role involves managing tender readiness, interacting with regional health authorities, and ensuring compliance across product lifecycles. Candidates must have 3-5 years of experience in the medical device industry with specific expertise in APAC regulatory frameworks. The position requires strong cross-functional collaboration with clinical and commercial teams to drive business objectives.
TAL's take
Solid role at an established healthtech company with clear regional scope and regulatory responsibilities.
The JD provides a highly specific list of responsibilities, regional regulatory frameworks, and required experience levels.
Must haves
- Minimum 2 years experience in medical device Class II/III environment
- Bachelor's degree in Life Sciences, Pharmacy, or related field
- 3-5+ years regulatory affairs experience in medical device or healthcare
- Strong experience supporting JPAC regulatory environments
- Expertise in regulatory submissions and approvals across multiple APAC countries
Tools and skills
About the company
Established medical technology company, tier 2 status.
Posts mentioning Masimo
Apple Watch Bannned!
Apple Watch Series 9, Watch Ultra 2 no longer available for online purchase in US. This happened due to a patent dispute over their blood oxygen sensor technology with health tech company Masimo. The smartwatches will be available for purchase on offline retail stores in the US till December 24, reported TechCrunch.
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