Sr. Associate, Quality Assurance & Regulatory Affairs

About the role

Alcon is seeking a Senior Associate to support its Quality & Regulatory Affairs function in Hong Kong. You will ensure products meet global, local and internal regulations while upholding the highest quality standards.

Key responsibilities

• Promote awareness of the Quality System and regulatory requirements across the affiliate.
• Ensure products comply with market authorisation, GMP, ISO 13485, EU‑MDR, GDP and other local regulations.
• Review and approve Quality Assurance Agreements, batch releases, product returns and annual quality reviews.
• Participate in self‑inspections, supplier qualifications, CAPA, change control, risk management and KPI monitoring.
• Lead audit preparation for GxP suppliers and support external audits by Notified Bodies and Health Authorities.
• Contribute to regulatory strategies, submission plans and intelligence for new and existing products.
• Review local labelling, advertising and promotional materials for regulatory compliance.
• Investigate non‑conformances, conduct root‑cause analysis and implement corrective and preventive actions.

Required profile

• BSc in a scientific or engineering discipline.
• 2‑5 years experience in quality or regulatory affairs within medical devices or pharmaceuticals.
• Knowledge of 21 CFR Part 820, ISO 13485 and local legislation; experience with Hong Kong DOH preferred.
• Fluent in Cantonese and English (written and spoken); Mandarin a plus.
• Strong customer‑oriented communication and cross‑functional collaboration skills.

Required skills

• ISO 13485
• EU‑MDR
• 21 CFR Part 820
• GMP and GDP compliance
• CAPA, risk management and change control processes
• Regulatory submission and intelligence gathering
• Audit preparation and execution
• Standard office software (e.g., MS Office)

What we offer

• Competitive compensation and career advancement opportunities.
• Inclusive, collaborative culture that values diversity.
• Chance to make a meaningful impact on global eye health.