job description
Join Cooper Vision, a global leader in contact lens innovation, as a Senior RAQA Specialist for the Southeast Asia (SEA) market. In this pivotal role, you will drive regulatory approvals and ensure compliance with quality management systems (QMS) to support seamless product launches across the region.
Based in the vibrant hub of Denpasar, Bali, you will collaborate with cross-functional teams to navigate complex regulatory landscapes, maintain high standards of quality, and accelerate market access for cutting-edge eye care solutions. This is a unique opportunity to shape the future of vision health in SEA while enjoying the dynamic work-life balance of Bali’s professional ecosystem.
If you are a detail-oriented regulatory expert with a passion for quality assurance and a track record in medical device or healthcare compliance, we invite you to apply and contribute to our mission of improving lives through innovation.
Responsibility
- Lead the preparation, submission, and follow-up of regulatory dossiers for contact lens products to obtain timely approvals in SEA markets (e.g., Indonesia, Malaysia, Singapore, Thailand).
- Ensure compliance with local and international regulatory requirements, including ASEAN MDD, FDA, and ISO standards.
- Collaborate with R&D, manufacturing, and marketing teams to align product development with regulatory strategies and launch timelines.
- Maintain and update the Quality Management System (QMS) in accordance with ISO 13485 and other applicable standards.
- Conduct risk assessments and implement mitigation strategies for regulatory and quality-related risks.
- Monitor and interpret regulatory changes in SEA, providing proactive guidance to internal stakeholders.
- Support audits and inspections by regulatory authorities, ensuring all documentation and processes meet requirements.
- Train and mentor junior team members on regulatory affairs and quality assurance best practices.
Qualifications
- Bachelor’s degree in Pharmacy, Life Sciences, Biomedical Engineering, or a related field. Advanced degrees (MSc/MBA) are a plus.
- Minimum 5 years of experience in Regulatory Affairs (RA) and Quality Assurance (QA) within the medical device, pharmaceutical, or healthcare industry.
- Proven track record of successful product registrations in SEA markets, with familiarity with ASEAN regulatory pathways.
- In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and ASEAN MDD requirements.
- Strong analytical, problem-solving, and project management skills with the ability to manage multiple priorities.
- Excellent communication and negotiation skills in English; proficiency in Bahasa Indonesia or other SEA languages is advantageous.
- Experience with QMS software (e.g., MasterControl, TrackWise) and regulatory submission platforms (e.g., eCTD).
- Ability to work independently in a fast-paced, remote or hybrid environment with a focus on Bali-based operations.