Stryker
Website:
stryker.com
Job details:
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.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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