RAQA Manager M F D

Your Mission

Regulatory Affairs and Quality Assurance

• Ensure company operations comply with applicable regulatory requirements, including FDA Philippines regulations and other relevant government standards.
• Prepare, compile, and submit regulatory dossiers and applications (registrations, notifications, variations, and reports) to the FDA Philippines in accordance with regulatory timelines and company requirements.
• Manage post-market surveillance activities, including monitoring and reporting of complaints, adverse events, CAPA, FSCA, and product recalls until proper closure and documentation.
• Support and maintain the ISO 9001:2015 Quality Management System, including participation in Internal Quality Audits (IQA), preparation of Corrective Action Reports (CAR), process documentation, and contribution to Management Review activities.
• Serve as the liaison between regulatory authorities and internal departments, responding to regulatory inquiries and ensuring timely communication of regulatory requirements to relevant stakeholders.
• Provide regulatory guidance and technical support to internal teams and third-party distributors to ensure compliance with regulatory and company standards.
• Develop and maintain departmental procedures, standards, and documentation to ensure efficient regulatory and quality processes.
• Provide regulatory intelligence by monitoring regulatory developments, guidance updates, and enforcement trends, and translating these into actionable recommendations for internal and external stakeholders.
• Coordinate with operations and cross-functional teams regarding technical product information and regulatory compliance requirements.
• Support regional RA/QA in driving cross-functional regional strategic initiatives and shared services to strengthen regulatory compliance, quality system effectiveness, process harmonization, and overall operational excellence across Southeast Asia + Taiwan (SEAT) region.
• Perform other duties related to regulatory affairs and quality assurance as required to support business and compliance objectives.
  
  

• Review of Ethical Marketing and Compliance Programs, ensuring alignment with the APACMed Code of Conduct, company policies, and applicable healthcare compliance regulations.
• Drive risk management initiatives by identifying, assessing, and mitigating potential compliance risks related to commercial activities, third-party engagements, and operational processes.
• Act as the primary liaison for legal and compliance documentation, including Distributor Agreements, Accreditations, and Third-Party Due Diligence, coordinating with internal stakeholders and regional/legal teams to ensure proper review and compliance.
• Oversee third-party compliance management, including onboarding, due diligence reviews, and risk assessments for distributors, vendors, and business partners.
• Conduct compliance orientation and training programs for third-party vendors and distributors, anti-corruption requirements, and company compliance policies.
• Provide advisory support to internal teams on compliance matters related to marketing activities, sponsorships, engagements with healthcare professionals (HCPs), and external partnerships.
  
  

• Must possess Bachelors/College Degree in Pharmacy (Pharmacy/Pharmacology) or equivalent.
• Licensed Pharmacist
• Minimum 7 years working experience in the Regulatory Affairs Medical Device industry; with at least 2 years of management experience.
• Extensive knowledge of applicable local government regulations.
• Strong understanding of ASEAN Medical Device Directive (AMDD) and EU Medical Device Regulation (MDR)
• Good working knowledge of Good Distribution Practice (GDP) and ISO 9001; experience with audits, inspections, and QMS implementation is essential.
• Ability to inform and educate managers and department heads on regulations and polices that require regulatory affairs compliance.
• Excellent written and verbal communication skills.
• Excellent analytical and problem-solving skills.
• Excellent strategic planning skills.
• Proficient with applicable database and compliance software.
• Proficient with Microsoft Office Suite or required software.
  
  

• Leave Benefits (Vacation Leave, Sick Leave, Parental Leave, etc.)
• Birthday Benefits
• Transport Allowance (if applicable to role)
• Accessibility to Public Transport
• Flexible Work Arrangements
• Group Health Insurances (with 2 additional dependents)
• Wellness Programs and Activities
• Professional Development Opportunities
• Global Exposure & Business Travel Opportunities (if applicable to role)
• All other statutory benefits