Your Role

Responsible for regulatory strategy, submissions and approvals for new product registrations and life-cycle management of registered products, and ensure regulatory compliance is maintained for Meditec, Vision Care, RMS and IQS. Act as a Quality Management Representative for Carl Zeiss Philippines to lead both internal and external audit.

Key Responsibilities

• Lead regulatory affairs and licensing operations to ensure compliance with Philippines FDA and local regulatory requirements across ZEISS Business Segments.
• Plan, execute, and manage product registrations, variations, renewals, and import permits; coordinate with HQ, regional teams, and local authorities to meet timelines.
• Develop and implement regulatory strategies to support business objectives, accelerate approvals, and ensure market access.
• Oversee post-marketing surveillance activities, including product complaints, adverse event reporting, FSCA, and recalls.
• Act as Quality Management Representative, overseeing internal and external audits and ensuring effective implementation of the Quality Management System.
• Provide regulatory guidance for product launches, tenders, labeling, claims, promotional materials, and due diligence activities.
• Monitor regulatory changes, assess risks, and communicate impacts to stakeholders; represent the company with regulatory agencies and industry associations.

Education

• Degree in Pharmacy, Chemistry, Biology, or related sciences.

Experience

• At least 8 years of relevant experience in the field of Medical Device regulatory affairs in the Philippines

• Strong knowledge of FDA Philippines regulations.

• Good understanding of GDPMD / ISO 13485 Quality Management System

• Well-versed with new products, variations and renewals of medical device registration.

• Certified internal auditor for GDPMD / ISO 13485 is an added advantage.

Other Skills

• Strong analytical and strategic thinking skills. Ability to work independently, analyze complex problems, and proactively take initiatives.

• A strong ability to understand business needs and impact of regulatory issues.

• Strong oral and written communication skills, fluent in English, with the ability to convey strategic and tactical issues to management.

• Excellent negotiation and project management skills.

• Commitment to achieve excellence with a strong work ethic and results orientation.

Your ZEISS Recruiting Team:

Chloe Tan