Regulatory Affairs Lead - Medical Devices & Cosmetics

Andaman Medical; Philippines; On-site; PHP 700,000 - 1,200,000; Full time

Job summary

Andaman Medical in the Philippines is seeking a Regulatory Affairs Lead to guide product registration and ongoing compliance for medical devices, foods, and cosmetics. You will develop strategies, advise on classifications, and ensure timely approvals across multiple markets.

The role requires strong regulatory writing, stakeholder management, and cross-functional collaboration to support post-market activities and ongoing regulatory updates.

Qualifications

• Bachelor’s Degree, Post-Graduate Diploma, Professional Degree in Biology, Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent.
• Licensed Pharmacist preferred.
• Minimum of 3–5 years of Regulatory Affairs experience.
• Experience with Medical Device, Food/Food Supplements, and Cosmetics regulatory categories.
• Strong regulatory writing and documentation skills.
• Excellent communication and stakeholder management abilities.

Responsibilities

• Serve as the regulatory lead for assigned clients and provide regulatory consultation throughout the product lifecycle.
• Develop regulatory strategies based on country-specific requirements and business objectives.
• Advise clients on product classification, regulatory pathways, documentation requirements, and market entry strategies.
• Conduct gap assessments of technical documentation and provide recommendations for regulatory compliance.
• Interpret and communicate regulatory requirements to both internal teams and external clients.
• Manage end-to-end regulatory submissions for healthcare products, including medical devices, food and cosmetics.
• Prepare, review, and compile regulatory dossiers; verify completeness of submission documents.

Skills

Regulatory writing

Stakeholder management

Project management

English proficiency

Education

Bachelor’s degree or equivalent

Licensed Pharmacist (preferred)

Tools

Microsoft Office

Job description

Andaman Medical in the Philippines is seeking a Regulatory Affairs Lead to guide product registration and ongoing compliance for medical devices, foods, and cosmetics. You will develop strategies, advise on classifications, and ensure timely approvals across multiple markets.

The role requires strong regulatory writing, stakeholder management, and cross-functional collaboration to support post-market activities and ongoing regulatory updates.