Global QA & Regulatory Affairs Specialist

Alcon MX; Hong Kong; On-site; HKD 600,000 - 900,000; Full time

Benefits offered by this job

Competitive compensation package

Job summary

Alcon Hong Kong seeks a Quality & Regulatory Affairs professional to ensure products meet global, local, and internal regulations and quality standards.

You will drive compliance across the affiliate, collaborate with stakeholders, manage GMP, ISO13485, and market authorizations, and support audits by Health Authorities. The role offers growth in a global eye-care leader with opportunities to contribute to patient care.

Qualifications

• BSc in scientific/engineering field.
• 2–5 years in quality or regulatory in medical devices or pharma.
• Knowledge of 21 CFR part 820, ISO13485 and local laws.
• Hong Kong DOH engagement preferred.
• Fluent in Cantonese and English; Mandarin preferred.

Responsibilities

• Promote awareness of the Quality System and regulatory requirements across the affiliate.
• Ensure products comply with market authorization, GMP and local regs.
• Lead QMS activities: CAPA, audits, SOP compliance.
• Support audits by Notified Bodies and Health Authorities.
• Contribute to regulatory strategies to support product lifecycle and market access.
• Prepare regulatory submissions and maintain records; respond to regulatory requests.

Skills

Fluent Cantonese

Fluent English

Mandarin preferred

Customer oriented communication

Cross-functional collaborator

Collaborative team member

Computer literacy

Education

BSc Degree in a Scientific or Engineering discipline

Job description

Alcon Hong Kong seeks a Quality & Regulatory Affairs professional to ensure products meet global, local, and internal regulations and quality standards.

You will drive compliance across the affiliate, collaborate with stakeholders, manage GMP, ISO13485, and market authorizations, and support audits by Health Authorities. The role offers growth in a global eye-care leader with opportunities to contribute to patient care.