Regulatory Affairs Associate

About the role

The Regulatory Affairs Associate will support the company in meeting all government regulations related to medical device importation and distribution. The role involves managing licences, ensuring compliance with FDA and other local authorities, and supporting quality and safety initiatives.

Key responsibilities

• Initial registration and life‑cycle management of product licences, including maintaining the License to Operate as a Medical Device Importer/Distributor.
• Design and implement regulatory strategies to meet licensing and registration timelines.
• Coordinate regulatory alignment with foreign suppliers for FDA updates and changes.
• Serve as the primary contact for regulatory queries from suppliers in the Philippines.
• Assist inspectors during FDA audits and ensure proper record‑keeping in compliance with FDA rules.
• Obtain clearances from non‑FDA bodies such as OMB and NTC, and review promotional material copies.
• Monitor regulatory changes, participate in industry meetings, and take corrective actions to mitigate risk.
• Prepare and update SOPs, work instructions, and policies as needed.
• Handle product complaints, field actions, and act as point person during supplier audits.

Required profile

• Bachelor’s degree in Pharmacy.
• Registered Pharmacist.
• New graduates are welcome to apply.

Required skills

• Knowledge of FDA regulations for medical devices.
• Experience with medical device licensing and importation.
• Regulatory compliance expertise.
• Ability to develop and maintain SOPs and work instructions.