- 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.
- 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
Quote job ref
+63 02 7795 2813