• As a Regulatory Affairs Officer, you will be responsible for ensuring that our medical devices meet all necessary regulatory requirements and standards.
• Your key responsibilities will include product registration, compliance management, documentation and reporting, pharmacovigilance, communication and collaboration, and staying updated with regulatory changes. You will work closely with cross-functional teams to facilitate regulatory submissions and maintain compliance with FDA regulations.

Product Registration:

• Prepare and submit comprehensive registration dossiers for medical devices.
• Manage the renewal process for existing product registrations.
• Monitor the status of registration applications and address any queries from the FDA.

B. Compliance Management:

• Ensure adherence to all applicable regulatory guidelines regarding medical device labeling, packaging, and advertising.
• Review and approve marketing materials to ensure accuracy and compliance with regulatory requirements.
• Conduct regular internal audits to identify potential compliance issues and implement corrective actions.

C. Documentation and Reporting:

• Maintain accurate and up-to-date regulatory documentation for all products, including product specifications, stability studies, and batch records.
• Prepare and submit periodic reports to the FDA as required, such as adverse event reports and safety updates.

D. Pharmacovigilance:

• Monitor and evaluate adverse reactions reported by healthcare professionals and consumers.
• Report serious adverse events to the FDA according to established procedures.

E. Communication and Collaboration:

• Collaborate with cross-functional teams including research and development, quality assurance, and marketing to facilitate regulatory submissions and compliance.
• Liaise with the FDA on regulatory issues and provide necessary information for inspections.

F. Staying Updated:

• Actively monitor changes in the regulatory landscape and implement necessary updates to company procedures.
• Attend industry conferences and workshops to stay informed about new regulatory requirements.

E. Qualifications:

• Bachelor of Science in Pharmacy degree.
• With or without a license.
• With or without experience, but experience is a must.
• Strong understanding of Philippine FDA regulations and guidelines.
• Excellent written and verbal communication skills.
• Ability to work under pressure with minimum supervision.
• Willingness to undergo training.
• Excellent analytical skills.