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 (Based in Alabang ofifice)
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
