Alcon

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 Regulatory Affairs Manager, you are required to manage all facets of regulatory support to Alcon medical device products. This includes developing regulatory submissions, maintaining the approved product licenses/ QSDs, and coordinating regulatory affairs activities in compliance with Health Authority’s regulations and inter-company procedures. Managing departmental projects, providing guidance and consultation for regulations, interacting with government authority, and managing a staff of regulatory professionals. Manage regulatory improvement projects and resolves complex problems that have implications beyond own area of responsibility. Requires professional expertise and interpersonal skills to manage multiple projects and interface with personnel from all company disciplines and business units. An understanding of Alcon products and their use as well as an understanding of the regulations pathways is required. In this role, a typical day will include:

• Manage the product approval activities such as product registration and product change management to facilitate and ensure timely introduction of new products according to business needs
• Be knowledgeable of the latest regulatory and corporate requirements concerning regulatory and update the necessary processes and procedures in Taiwan, supporting regular updates to Global & APAC RA as required
• Closely work with commercial, S&OP, global RA, Life Cycle Management and external partners to develop new artwork and ensure the success of product launch
• Ensure the good license maintenance and document filing
• Define and implement Taiwan regulatory strategic plans with Dept. Head
• Oversee promotional materials review, relevant activities, and publications to comply with all relevant internal policies and local country regulations
• Manage internal and cross-functional projects

What you’ll bring to Alcon:

• Bachelor degree - major in life sciences or equivalent field
• 8 years regulatory affairs work experiences in multinational medical device companies. Preferred 10 years regulatory affairs work experiences in multinational medical device companies, focused on vision care, implants and equipment medical devices
• Good command of communication in English and Mandarin (speaking, reading, and writing)
• Thorough knowledge of regulatory requirements, promotional materials review, and product life cycle management
• Be able to work independently, with the ability to multi-task assignments
• Superior interpersonal and communication skills
• Proactive in taking initiative and prioritizing pipeline projects
• Strong computer skills (Microsoft Office)
• Ability to function well as a member of the team and build relationships between RA and other areas of the organization
• Responsible, professional, detail oriented and with patience
• Able to identify and assess business risks for a given RA strategy as a problem-solver

How You Can Thrive at Alcon:

• Opportunity to work with a leading global medical device company.
• Collaborate with a diverse and talented team in a supportive work environment.
• Competitive compensation package and comprehensive benefits.
• Continuous learning and development opportunities.

Alcon Careers

See your impact at alcon.com/careers