Associate/Manager, Regulatory Affairs, Philippines at ZEISS Group

Muntinlupa, Metro Manila, Philippines -

Full Time

Start Date

Immediate

Expiry Date

27 Jun, 26

Salary

0.0

Posted On

29 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Product Registrations, Life-Cycle Management, Regulatory Compliance, Quality Management System, Internal Audit, External Audit, FDA Philippines Regulations, GDPMD, ISO 13485, Post-Marketing Surveillance, Risk Assessment, Project Management, Strategic Thinking, Negotiation, Communication

Industry

Machinery Manufacturing

Description

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 Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together. Join us today. Inspire people tomorrow. Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity. Apply now! It takes less than 10 minutes.

Responsibilities

The role is responsible for leading regulatory affairs and licensing operations to ensure compliance with Philippines FDA requirements across various ZEISS Business Segments. This includes planning and managing product registrations, variations, renewals, and overseeing post-marketing surveillance activities.