Raqa Manager (m/f/d)

KARL STORZ SE & Co. KG

Taguig City, Philippines
On-site
Fda philippines regulations
Iso 9001:2015 quality management system
Post-market surveillance
KARL STORZ SE & Co. KG is seeking a Raqa Manager in Taguig City, Philippines, focused on regulatory affairs and quality assurance for the medical device industry. The ideal candidate will have extensive experience in regulatory compliance, management skills, and a strong understanding of local and international regulations

Job Summary

  • Ensure company operations comply with applicable regulatory requirements, including FDA Philippines regulations and other relevant government standards.
  • Manage post-market surveillance activities, including monitoring and reporting of complaints, adverse events, CAPA, FSCA, and product recalls until proper closure and documentation.
  • Provide regulatory guidance and technical support to internal teams and third-party distributors to ensure compliance with regulatory and company standards.

Matching Summary

Match Score: 85

KARL STORZ SE & Co. KG is seeking a Raqa Manager in Taguig City, Philippines, focused on regulatory affairs and quality assurance for the medical device industry. The ideal candidate will have extensive experience in regulatory compliance, management skills, and a strong understanding of local and international regulations.

Skills & Requirements

Must-have

  • FDA Philippines regulations
  • ISO 9001:2015 Quality Management System
  • post-market surveillance
  • regulatory intelligence
  • APACMed Code of Conduct
  • third-party compliance management

Nice-to-have

  • cross-functional regional strategic initiatives
  • process harmonization
  • operational excellence

Key Requirements

  • Bachelor's/College Degree in Pharmacy or equivalent
  • Licensed Pharmacist
  • Minimum 7 years' experience in Regulatory Affairs Medical Device
  • At least 2 years of management experience
  • Extensive knowledge of local government regulations
  • Strong understanding of AMDD and EU MDR
  • Good working knowledge of GDP and ISO 9001

Work Rights

Not specified

Tailored Resume

Cover Letter