Sr. Associate, Quality Assurance & Regulatory Affairs

Alcon; Hong Kong; On-site; HKD 550,000 - 750,000; Full time

Job summary

Alcon seeks a Regulatory & Quality professional in Hong Kong to ensure global and local regulatory compliance for medical devices and pharmaceuticals. The role focuses on Quality System governance, regulatory submissions, audits, and cross-functional collaboration to uphold GMP/ISO13485 standards.

Ideal candidates hold a science/engineering degree with 2–5 years in QRA, fluent in Cantonese and English, and with Mandarin preferred.

Qualifications

• BSc in a Scientific or Engineering discipline or related field.
• 2–5 years in quality or regulatory environment in medical devices or pharmaceutical business with knowledge of 21 CFR part 820, ISO13485 and local regulations.
• HK DOH experience preferred.
• Fluent in Cantonese and English; Mandarin (Putonghua) preferred.

Responsibilities

• Drive awareness of the Quality System and regulatory requirements across the affiliate as a strategic platform for the business.
• Ensure products comply with market authorization and GMP requirements and are handled according to regulatory requirements.
• Participate in QMS activities: self-inspections, CAPA, change control, risk management, SOP compliance.
• Participate in audits of suppliers and Notified Bodies; support external audits as needed.
• Contribute to regulatory plans, submissions, approvals, and maintenance of records for new and life-cycle products.
• Monitor and report regulatory intelligence and maintain stakeholder alignment with global/regional strategies.

Skills

Cantonese fluent

English fluent

Mandarin preferred

Cross-functional collaboration

Communication skills

Education

BSc in science or engineering

Job description

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

Overview

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly.

Major Accountabilities

• Drive awareness of the Quality System and of regulatory and customer requirements throughout the affiliate as a strategic platform for the business. Works in close collaboration with internal stakeholders and supports multiple projects with high standards of compliance to the regulatory and quality systems requirements.
• Work with QRA leadership to ensure that products comply with market authorization and GMP requirements and are received, stored, handled, released, distributed and transported according to regulatory requirements including but not limited to ISO 13485, EU-MDR (if applicable to the region/country), GDP and relevant local requirements. Review documentation including Quality Assurance Agreements and approve incoming batches of medicinal products and /or medical devices (as applicable per market) product returns and annual product quality reviews as required per local market.
• Participate as needed in all activities required for an effective Quality Management System including but not limited to, self-inspections, supplier qualifications and monitoring, CAPA process, management review, change control, risk management, Quality Planning, key performance indicators and SOP compliance.
• Participate in audits of GxP suppliers, and self-inspection program, lead external audit preparation activities (as applicable) and contribute to external audits by Notified Bodies and Health Authorities as needed.
• Contribute to the regulatory strategies to optimize the commercial success of marketed products, collaborating with both GRA and other functions to ensure stakeholder input is integrated into the overall global strategies.
• Contribute to regulatory plans, for submissions, approvals, regulatory impact assessments, and maintenance of all records of clinical trial and marketing authorization applications for all new products and life cycle management of marketed products in the country/cluster/region (as applicable).
• Monitor and provide regulatory intelligence on regulations related to Alcon Products, guidance and policy proposals impacting Alcon’s products or processes.
• Contribute as needed to negotiations with internal and external stakeholders (e.g. Health Authorities, GRA and commercial teams) to help align optimized regulatory strategies to achieve business objectives.
• Perform local labelling, advertisement and promotional materials review and approval (as applicable) in compliance with Global and local regulatory requirements.
• Responds to regulatory requests from across the organization in a timely manner.
• Support initiatives to drive performance and ensure alignment with established KPIs, resulting in consistent goal attainment and operational excellence
• Ensure appropriate and timely escalation of quality events to management. Support when needed, the Management of market actions (FSCAs, recalls, etc.) and report to the Health Authority in compliance with Corporate QA requirements and local regulations.
• Perform non-conformance investigations and provide guidance as needed ensuring formal structured approach to root cause analysis and problem solving, ensuring adequate corrective actions and prevention plans are implemented.

All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

Required Qualifications

• BSc Degree in a Scientific or Engineering discipline or related field
• Proven experience (at least 2 - 5 years) in Quality or Regulatory environment in medical devices or pharmaceutical business including comprehensive knowledge of 21 CFR part 820, ISO13485 and local applicable legislations.
• Previous engagement experience with Hong Kong DOH (Department of Health) is preferred.
• Fluent in Cantonese and English, both written and spoken.
• Mandarin (Putonghua) communication skills are preferred.
• Customer oriented Communication Skill
• Cross-functional collaborator and Collaborative team member
• Computer literacy with standard software platforms
• Any other specific local country qualification requirements must also be met.

Why join Alcon?

• Join a global leader with a rich history of innovation and excellence in eye care.
• Be part of a collaborative and supportive team culture that values diversity and inclusion.
• Enjoy a competitive compensation package and opportunities for career advancement.
• Make a meaningful difference in the lives of patients worldwide by contributing to cutting-edge advancements in eye health.