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Stryker · Bengaluru, India

# Senior Regulatory Specialist

Bengaluru, India Senior individual contributor Legal & Compliance 

Listed on Stryker’s official careers site. Listed as of October 18, 2026. Check that it is still open and apply there.
[Apply on Stryker’s careers site →](https://stryker.wd1.myworkdayjobs.com/StrykerCareers/job/Bengaluru-India/Senior-Regulatory-Specialist_R570427-3)

[OpenNash Jobs](https://jobs.opennash.com/) / [Stryker](https://jobs.opennash.com/companies/stryker/) / Senior Regulatory Specialist

## Job description

### Work Flexibility

Hybrid What you will do-
- Lead regulatory support for New Product Introduction (NPI) and sustaining activities in designated APAC markets, including Hong Kong, Singapore, Macau, and Taiwan.
- Prepare, compile, review, and submit regulatory dossiers, registrations, renewals, amendments, and notifications in accordance with local regulatory requirements.
- Assess the regulatory impact of product, labelling, manufacturing, supplier, specification, and design changes and determine required regulatory actions.
- Maintain product registrations and licenses throughout the product lifecycle, ensuring continued compliance with applicable regulations and market requirements.
- Coordinate with regional regulatory teams, distributors, and in-country representatives to support regulatory submissions and market access activities.
- Monitor regulatory commitments, submission timelines, approval status, and renewal requirements to ensure uninterrupted product availability.
- Review technical documentation, product information, labelling, and other supporting records for completeness, accuracy, and regulatory compliance.
- Support post-market regulatory activities, including field actions, vigilance-related submissions, product updates, and compliance requests as required.
- Maintain regulatory records, databases, and document repositories in accordance with internal procedures and document control requirements.
- Track changing regulatory requirements within assigned markets and assess the impact on existing products and planned product launches.
- Collaborate with Quality, R&D, Product Engineering, Operations, Marketing, and Supply Chain teams to obtain required documentation and support regulatory deliverables.
- Independently manage multiple projects and priorities while delivering high-quality regulatory outputs within established timelines.
- Identify opportunities for process improvements, standardization, and efficiency enhancement across APAC regulatory activities.
- Support internal and external audits, inspections, and compliance assessments by providing regulatory documentation and subject matter expertise.
- Proactively communicate project risks, regulatory concerns, and potential market access impacts to stakeholders and management.

### What you will need

Required Skills-
- Bachelor's or Master's degree in Engineering, Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline.
- Experience - 5 years- 7 years and relevant 3 years of experience in Regulatory Affairs within the medical device, healthcare, pharmaceutical, or life sciences industry.
- Experience supporting product registrations, renewals, amendments, and lifecycle management activities across APAC markets; supporting NPI and sustaining engineering activities from a regulatory perspective; working with regulatory information management systems, PLM systems, document control systems, or equivalent tools is preferred.
- Working knowledge of regulatory requirements for Hong Kong, Singapore, Macau, Taiwan, or other international medical device markets.
- Familiarity with technical documentation, design control, change control, and product lifecycle management processes.
- Strong understanding of global regulatory frameworks and quality management principles applicable to medical devices.
- Ability to perform regulatory impact assessments and independently determine submission strategies for changes.
- Strong analytical, problem-solving, organisational, and project management skills.
- Excellent written and verbal communication skills with the ability to collaborate effectively across global teams.
- Ability to manage multiple priorities with minimal supervision in a fast-paced environment. Preferred Skills -
- Knowledge of ASEAN medical device regulations and international regulatory requirements.
- Experience working with distributors, local country representatives, and external regulatory partners; global product portfolios and cross-regional regulatory initiatives.
- Familiarity with UDI, product registration databases, and post-market regulatory processes.

### Travel Percentage

10%

## At a glance
- Posted by the employer: Not stated
- First seen by OpenNash: Aug 21, 2026
- Last checked: Oct 18, 2026
- Listed for: 58 days
- Location: Bengaluru, India[Apply on Stryker’s careers site →](https://stryker.wd1.myworkdayjobs.com/StrykerCareers/job/Bengaluru-India/Senior-Regulatory-Specialist_R570427-3)

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