Senior RA/QA Executive (m/f/d)

Your Mission

• Coordinate Regional Regulatory Submissions (New/Extension Products/Trading Goods)
• Support and track timely submissions for product registrations, renewals, and variations across multiple APAC markets in collaboration with country RA teams. Consolidate and review documentation packages to ensure consistency, quality, and alignment with regional standards.

• Regulatory Intelligence & Gap Assessments: Monitor evolving APAC regulations and support impact assessments. Help ensure readiness and compliance with new requirements through updates to SOPs, templates, or submission strategies.

• Liaise with Country RA Teams as regional contact point to Global RA staff and suppliers, providing guidance on submission processes, documentation, and regulatory expectations. Escalate issues and align on best practices across countries.

• Ad-hoc Regional QMS Coordination
• In event of Quality issues - ensure timely post-market surveillance reporting until closure (complaints, adverse events, FSCA, recalls). Coordinate the closure of open PFAs with local RA teams and update relevant vigilance trackers. Ensure timely collection of close-out letters and compliance with regional timelines. Screen reminders from Global Vigilance and support local QA teams in decision-making.

• Regional Data and Reporting: Maintain dashboards and trackers for regulatory submissions, quality metrics, and compliance status across APAC markets.

• Change Management & MDR Migration: Review and assess change notifications (ECMs) for APAC impact. Coordinate with affiliate teams to gather documents required for local submissions. Maintain the APAC Change Notification Tracker and MDR Migration Tools. Ensure all MDR-related updates are implemented and tracked across APAC markets.

• Support Cross-Functional & Process Improvements
• Train local teams on tools, systems, and Regulatory/QA requirements
• Maintain regulatory and quality database(s).
• Review and revise internal SOPs regularly - Maintaining knowledge and understanding of Standard Operating Procedures.

• Ad-Hoc support: Act as a flexible point of contact for subsidiary-level needs that intersect with regional objectives. Support emerging projects, pilot programs, or escalations as directed by the Regional Director or global RAQA teams. Provide timely assistance for unplanned documentation requests, authority inquiries, and urgent compliance matters.

Your Talents

• Recognized Diploma / Degree in relevant studies
• More than 3 years experience in RAQA for medical device industry
• Strong interpersonal and communication skills
• Meticulous attention to details
• Proficient in Both spoken and written English
• Provicient in Computer skills, Micosoft office
• Good time management skills are highly essential

Your Benefits

• Leave Benefits (Vacation Leave, Sick Leave, Parental Leave, etc.)
• Birthday Benefits
• Transport Allowance (if applicable to role)
• Accessibility to Public Transport
• Flexible Work Arrangements
• Group Health Insurances
• Flexi-Benefit Reimbursement
• Wellness Programs and Activities
• Professional Development Opportunities
• Global Exposure & Business Travel Opportunities (if applicable to role)
• All other statutory benefits