Associate/Manager, Regulatory Affairs, Philippines job opportunity at Zeiss Group.

Home Jobs In Philippines Tag: Regulatory Affairs, Philippines Associate/Manager, Regulatory Affairs, Philippines position at Zeiss Group


DateMore Than 30 Days Ago bot
Zeiss Group Associate/Manager, Regulatory Affairs, Philippines
Experience: 8-years
Pattern: full-time
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Regulatory Affairs, Philippines

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loacation Muntinlupa City, Philippines
loacation Muntinlupa Cit..........Philippines

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

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