RA/QA Manager- Medical Device
World leading brand in the field
Strategic leader of a team of experienced RA and QA professionals
About Our Client
Global leading medical device provider dedicated in delivering innovative product solutions to improve patient's health worldwide.
The company is known for it's premium quality products and professional approach.
- Manage company regulatory affairs including reports, license transfer, renewal etc. to ensure
compliant with government requirement and company standard.
- Determines and communicates regulatory changes and requirements
- Develop and maintain good and professional relationship with the regulatory authorities, legislators, trade
association etc. to ensure smooth and efficient registration process and influence for positive change of
- Implement corporate SOPs of GMP & GDP, safety/security policies/crisis management, product
complaints including other general SOPs as required to maintain good corporate practice, company
reputation and safeguard all company assets.
- Interface with regional and international management team to ensure regulatory strategies and
processes are in line with local business strategy.
The Successful Applicant
- More than 10 years of RA or QA experience in the Medical Devices industry with 7 years in leadership is required
- Strong knowledge of regulatory and legal requirements related to product registration processes for Medical Devices.
- Application of quality system and regulatory requirements from product concept through product distribution.
- Logical with great communication across different teams (Sales, Marketing...)
What's on Offer
Great career opportunity