Product Registration and Maintenance
- Analyze registration complexities and provide regulatory guidance to align with company’s business goals.
- Manage regulatory plans across Singapore and APAC for new and existing products, variations, modifications, renewals and compliance.
- Prepare technical dossiers for submission to regulatory authorities.
- Draft well-written responses to regulatory authorities’ inquiries
- Follow up on product license renewals.
- Support post-market regulatory activities (e.g. adverse reporting, recalls)
Quality Management System Compliance
- Maintain a thorough understanding of relevant regulatory policies and ensure compliance.
- Prepare and uphold local SOPs and policies related to Regulatory Affairs in alignment with company standards and Regulatory Authority requirements.
- Provide regulatory input and support for company policies and activities to ensure compliance to relevant regulatory policies (e.g. marketing plans & materials, product artwork, change controls)
- Maintain organized regulatory files and product licenses.
Regulatory Intelligence
- Gather and analyze regulatory intelligence, integrating trends into decision-making processes.
- Stay updated on device regulations, changes, guidance, and standards relevant to product submissions, analyzing and providing updates as necessary.
Others
- Perform additional ad-hoc duties as assigned.
Requirements
- Degree in Life Sciences, Engineering, Pharmacy, Pharmaceutical Science or a related field.
- Minimum of 5 years’ experience in medical device industry.
- Possess a thorough understanding of Health Sciences Authority and overseas (e.g. APAC, EU Medical Device Directive/Regulation, US FDA) medical device regulations.
- Prior working experience in an ISO 13485:2016 environment is a plus.
- Understand business needs and the implications of regulatory issues.
- Excellent communication skills, with proficiency in written and spoken English.
- Proficiency in Microsoft Office.
- Independent, meticulous, detail-oriented, and proactive.
- Strong multitasking ability and a proactive approach.
- Positive attitude with a passion for learning and development.
- Ability to adapt in a fast-paced environment.
