Senior Specialist - Regulatory Affairs & Quality

Manila Permanent
  • Help establish a local entity of a global medical devices company
  • Spearhead systems in place for regulatory afffairs and quality management

About Our Client

A million-dollar enterprise providing medical solutions in the field of oncology and neuroscience.

Job Description

  • Prepare, submit, and manage regulatory applications required for product market approvals in Philippines 
  • Implement, maintain and support local submission processes and global processes 
  • Coordinate with local consultants and agents who support regulatory submissions 
  • Collate and prepare all materials, reports and follow-ups with regulatory agencies regarding recall activities 
  • Support post-market surveillance activities, i.e. complaint Investigations, FSCA, MDR, etc. 
  • Commits to quality - adheres to and improves processes and works 
  • Support in issuing and changing processes and procedures to fit in local statutory and regulatory requirement  Participate in internal and external quality system and design dossier audits 
  • Perform other ad hoc initiatives/activities as per request from the function

The Successful Applicant

  • Bachelor's Degree in a technical discipline such as Pharmacy, Medical Science, Health Science, Bio-medical Engineering, or Medical Engineering. 
  • Minimum of 2 years regulatory affairs experience in medical device industry 
  • Solid working knowledge and experience of Philippines regulations and standards applicable to medical device market clearance 
  • With a qualification as Qualified Person in Industry Regulatory Affairs (QPIRA) under Center for Device Regulation, Radiation, Radiation Health and Research, Certificate of Attendance of to an FDA-sponsored seminar on Licensing of Medical Device Establishment 
  • Experience in managing to obtain License to Operate (LTO), Medical Device Establishment License is a plus 
  • Experience in ISO 9001, ISO 13485 audit 
  • A structured approach to problem-solving with an appreciation of quality tools & techniques. 
  • An effective team player who can provide creative solutions - offers proposals and ideas to solve problems.
  • A positive attitude towards change to promote the global goals of the business. 
  • Able to work within a multi-cultural environment

What's on Offer

  • Flexible work arrangements
  • Competitive compensation and benefits package
  • Global and regional decision making prowess
Contact
Eds Enslie
Quote job ref
4207977
Phone number
+63 02 7795 2813

Job summary

Function
Location
Job Type
Consultant name
Eds Enslie
Consultant contact
+63 02 7795 2813
Job Reference
4207977