Senior Regional RA/QA Manager (m/f/d)

• Your Mission

  Regulatory Affairs: Lead product registration, renewals, and regulatory change management across SEAT. Anticipate regulatory shifts and advise SEAT leadership on market access implications. Represent SEAT in Regional RA strategy discussions. 

  Quality Compliance: Ensure full compliance with ASEAN regulations (HSA, GDPMDS) and international standards (FDA QSR, EU MDR, ISO 13485). Own SOP lifecycle management and policy alignment with global standards. Drive continuous improvement in quality systems and post-market surveillance. 

  Quality Governance: Own SOP lifecycle management and policy alignment with global standards. Embed risk-based compliance controls across business functions. Drive continuous improvement in quality systems and post-market surveillance.

   •    Regulatory Affairs: Lead product registration, renewals, and regulatory change management across SEAT. Anticipate regulatory shifts and advise SEAT leadership on market access implications. Represent SEAT in Regional RA strategy discussions.
  •    Quality Compliance: Ensure full compliance with ASEAN regulations (HSA, GDPMDS) and international standards (FDA QSR, EU MDR, ISO 13485). Own SOP lifecycle management and policy alignment with global standards. Drive continuous improvement in quality systems and post-market surveillance.
  •    Quality Governance: Own SOP lifecycle management and policy alignment with global standards. Embed risk-based compliance controls across business functions. Drive continuous improvement in quality systems and post-market surveillance.
  •    Build strong distributor relationships to achieve regulatory timelines and enforce compliance standards. Act as senior escalation point for distributor compliance issues.
  •    Responsible for all internal & external audits activities.
  •    Responsible for full RA/QA compliance to local regulations including SOP write-up, review and revision, and GDPMDS certification/recertification. 
  •    Serves as the Management Representative and liaison for contact with certification body/regulatory officials on quality issues 
  •    Responsible for issuance , distribution, and maintenance of SOPs 
  •    Train new employees on SOPs and local compliance regulations. Update existing employees on changes to the local regulations and the impact of these changes on the company’s SOPs.
  •    Supervise and manage the local RA/QA team performance across region
  •    Collaborate cross-functionally with other departments 
  •    Support management and other departments in areas that have an impact on the company profitability
  •    Support and work with other departments to develop positive team spirit and strengthen teamwork among all KARL STORZ staff

  Compliance Management
  •    Develop and maintain the organization's compliance program. 
  •    Monitor compliance with applicable laws, regulations, and corporate policies. 
  •    Review business processes to identify compliance risks. 
  •    Ensure implementation of compliance controls across all business functions. 

  
  Policy & Governance
  •    Draft and update corporate policies and Standard Operating Procedures (SOPs). 
  •    Ensure policies remain aligned with local regulatory requirements and global standards. 
  •    Coordinate policy communication and acknowledgement processes. 

  
  Risk Assessment
  •    Conduct periodic compliance risk assessments. 
  •    Identify areas of regulatory exposure and recommend mitigation measures. 
  •    Track remediation actions until completion. 

  
  Training & Awareness

  •   Design and deliver training programs covering RA/QA, anti-bribery, and anti-corruption. Ensure annual Code of Conduct certification and ongoing awareness initiatives.

  Investigations
  •    Support investigations relating to ethics, fraud, misconduct, or regulatory breaches. 
  •    Coordinate with HR, Legal, and management where required. 
  •    Maintain confidentiality throughout

   

  • Your Talents

    • Bachelor degree from a recognized university. 

    • More than 5 years RA/QA experience in medical diagnostic equipment, pharmaceutical, medical device distribution or  manufacturing environment 

    • Deep expertise in ASEAN regulatory frameworks (HSA, GDPMDS) and familiarity with international standards (FDA QSR, EU MDR, ISO 13485, GMP).

    • Proven track record of leading audits, managing compliance programs, and driving regulatory approvals.

    • Others: 

      • Strong leadership, influencing, and stakeholder management skills across diverse cultures.
      • Proactive and resourceful
      • Work independently and as a team
      • Able to self-motivate and seek out challenges
      • Clear and concise communication skill in spoken and written English.
      • Highly organized, detail-oriented, and decisive, with the ability to prioritize under pressure. Resilient, resourceful, and motivated to elevate RA/QA standards across the region.

       

Your Benefits

• 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
• Flexi-Benefit Reimbursement
• Wellness Programs and Activities
• Professional Development Opportunities
• Global Exposure & Business Travel Opportunities (if applicable to role)
• All other statutory benefits