Sr. RA Specialist

7 hours ago

Taipei Taipei City, Taiwan Alcon Full time $90,000 - $120,000 per year

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?

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.

The Sr. Regulatory Affairs Specialist is primarily responsible for coordinating regulatory compliance for Alcon's product portfolio, managing local initiatives, and supporting business requests for product and regulatory information. You will also participate in cross-functional teams for risk management and produce compliance metrics.

As the SME for ensuring strong business support from RA, such as acceleration of new product approval/launch and maintenance of current approved products.

Support and execute critical projects:

  • License remediation
  • Product changes
  • RF certification of legacy products

Extensive experience required: manages all medical device registrations , understands the specific hospital requirements (UDI, labeling, listing, tender); navigate complex TFDA regulations (labeling, recalls, advertisements); engage HA and local associations.

Business acumen & local sensitivity: Align regulatory priorities with business needs to accelerate launches and ensuring business continuity.

Other specifics include:

  • Perform specialized tasks to optimize outcomes and contribute to project goals
  • Coordinate product submissions, renewals, and updates by liaising with plants, agents, and authorities for timely approvals
  • Promotional material approval, ensuring ethical conduct and compliance with applicable national and international laws, codes, and regulations
  • Provide regulatory strategies for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage
  • Support products in the medical device families, ensuring adherence to all relevant regulations based on those product families
  • 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
  • Support the maintenance of approval information in the internal system or database

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 .

Qualifications: Associate shall have the appropriate education and experience to successfully perform the responsibilities/activities of this role.

ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

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