Medical Device Regulatory Affairs Specialist

Fixus Enterprises; Quezon City; On-site; PHP 446,400 - 669,600; Full time

Job summary

A healthcare company in Quezon City is seeking a Regulatory Affairs Officer responsible for ensuring compliance with FDA regulations concerning medical devices. Key tasks include managing registration dossiers, conducting compliance audits, and collaborating with cross-functional teams. Ideal candidates hold a Bachelor's degree in Pharmacy and possess strong communication and analytical skills. Experience in regulatory affairs is preferred but not required, and training will be provided.

Qualifications

• Experience with regulatory compliance is desirable, but fresh graduates may apply.
• Willingness to undergo further training is needed.

Responsibilities

• Ensure medical devices meet regulatory requirements and standards.
• Prepare and manage product registration dossiers and renewals.
• Review marketing materials for compliance with regulations.
• Maintain accurate regulatory documentation and report to FDA.
• Collaborate with teams for regulatory submissions.
• Stay updated with regulatory changes and implement updates.

Skills

Excellent written and verbal communication skills

Strong understanding of Philippine FDA regulations

Ability to work under pressure with minimum supervision

Excellent analytical skills

Education

Bachelor of Science in Pharmacy degree

Job description

A healthcare company in Quezon City is seeking a Regulatory Affairs Officer responsible for ensuring compliance with FDA regulations concerning medical devices. Key tasks include managing registration dossiers, conducting compliance audits, and collaborating with cross-functional teams. Ideal candidates hold a Bachelor's degree in Pharmacy and possess strong communication and analytical skills. Experience in regulatory affairs is preferred but not required, and training will be provided.