At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

As a Quality and Regulatory Affairs Manager supporting the affiliate organization, you will be trusted to ensure compliance with regulatory and quality system requirements and contribute to strategic improvements in Quality and Regulatory activities at the country or regional level based in Budapest.

In this role, a typical day will include:

• Ensure Regulatory and Quality Compliance: Represent the Quality and Regulatory Affairs (QRA) function at country/cluster/regional level, ensuring compliance with applicable regulations, standards (e.g., ISO 13485, EU-MDR, GDP), and internal quality system requirements
• Quality System Oversight and Improvement: Act as Quality Management Representative or delegate, maintaining and improving the Quality Management System (QMS), supporting audits, CAPA processes, and continuous improvement initiatives
• Product Lifecycle and Market Authorization Support: Oversee regulatory activities related to product submissions, approvals, and lifecycle management, ensuring compliance with market authorization and GMP requirements
• Stakeholder Engagement and Regulatory Strategy: Collaborate with internal and external stakeholders, including Health Authorities and global teams, to align on regulatory strategies that support business objectives and product success
• Training, Coaching, and Team Support: Promote a strong quality culture across the affiliate, coach junior QRA team members, and support efficient resource allocation within QA and RA functions
• Monitoring, Reporting, and Escalation: Monitor regulatory changes, report key quality indicators, manage market actions (e.g., recalls, FSCAs), and ensure timely escalation of quality events to leadership

WHAT YOU’LL BRING TO ALCON:

• Degree in a Scientific or Engineering discipline or a related field
• Minimum of 5 years of experience in Quality Assurance or Regulatory Affairs within the medical device or pharmaceutical industry
• In-depth knowledge of 21 CFR Part 820 and ISO 13485 standards
• Familiarity with EU-MDR, GDP, and other relevant international and local regulatory requirements
• Native-level proficiency in Hungarian and fluent English language skills are required
• Strong analytical and problem-solving skills, with experience in CAPA, audits, and QMS processes
• Excellent communication and collaboration skills across cross-functional and international teams

HOW YOU CAN THRIVE AT ALCON:

• Be part of a purpose-driven organization committed to improving people’s vision and quality of life worldwide
• Work in a collaborative and inclusive environment that values innovation, integrity, and continuous learning
• Gain exposure to global regulatory and quality standards while contributing to strategic initiatives at country and regional levels
• Benefit from professional development opportunities, including coaching, training, and cross-functional projects
• Thrive in a role where your expertise in compliance and quality systems directly supports patient safety and business success

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