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Raqa Manager

karlstorz.com Logo

KARL STORZ

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Location:
Philippines , Taguig City

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Category:
Health and Beauty

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Contract Type:
Not provided

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Salary:

Not provided
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Job Responsibility:

  • 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

Requirements:

  • Must possess Bachelor's/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
What we offer:
  • 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

Additional Information:

Job Posted:
March 25, 2026

Work Type:
Hybrid work
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