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Gurugram, 122001, IN
Job details
Work flexibility: Hybrid
Req ID: R538036
Employee type: Full Time
Job category: RAQA
Travel: 10%
Relocation: Yes
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Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
What you will do :
- Develop and execute regulatory strategies for product approvals in global markets (e.g., FDA, EU MDR, Health Canada, TGA, China NMPA, Japan PMDA).
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR 2017/745, and other international regulatory frameworks.
- Provide strategic regulatory input during product development, clinical evaluations, and post-market surveillance.
- Conduct regulatory risk assessments and advise leadership on global compliance requirements.
- Lead the preparation, submission, and approval of complex regulatory filings, including 510(k), CE Marking (Technical Files), and international registrations.
- Oversee labeling compliance, ensuring all claims meet regulatory requirements.
- Manage regulatory lifecycle activities, including change notifications, renewals, and market expansions.
- Oversee post-market regulatory requirements, including adverse event reporting, vigilance submissions, and field actions.
- Collaborate with R&D, Quality, Clinical, and Commercial teams to ensure regulatory alignment throughout the product lifecycle.
- Provide regulatory support for FDA inspections, ISO audits, Notified Body reviews, and internal audits.
- Mentor and train junior regulatory staff, sharing expertise and best practices.
- Monitor and interpret regulatory trends and policy changes, ensuring the company remains proactive in compliance.
What you will need :
- Education: Bachelor’s or Master’s degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field.
- Experience: 8+ years of regulatory affairs experience in the medical device industry.
- Expert knowledge of EU MDR, FDA regulations, ISO 13485, MDSAP, and other global regulatory requirements.
- Proven experience leading 510(k), PMA, CE Marking, and international regulatory submissions.
- Strong problem-solving and leadership skills, with experience in cross-functional collaboration.
- Ability to work independently while managing multiple complex projects.
- Regulatory Affairs Certification (RAC) or equivalent is a plus.