about the company
The client is a dominant player in the medical technology industry that revolutionized respiratory and sleep healthcare. A market leader in their field, this value-driven multinational organization commits itself to cultivate employees excellence and innovation, as well as constantly striving for customer satisfaction. In addition, they are driven by their passion to increase awareness of the need for this technology to the public masses who are largely underdiagnosed in their field of expertise. Their global continued success as well as their intention to optimize growth regionally has resulted in this search for a Marketing Manager
about the job
As a regulatory affairs associate, you will be responsible for a range of critical tasks that include:
- Ensure products in development projects are in compliance with all internal and external regulatory requirements.
- Prepare filings of regulatory documents and implement regulatory submissions plan in line with product development objectives
- Utilize knowledge of European regulations through maintaining Global and European technical dossiers for assigned projects.
- Being in control of change processes in ensuring compliance of products are in line with new regulations through supplying documentation.
about the manager/team
Reporting to the Regional Affairs Manager, you will provide full regulatory leadership across all product portfolio in the SEA region, in achieving the organization’s business goals and objectives.
skills & experience required
To be successful in this role, you have a strong proven experience of at least 2 years in regulatory affairs management with knowledge of European and international regulations and standards covering medical devices. Having knowledge in the STED format for international regulations is essential and experience in medical devices ISO certification and testing standards is advantageous.
To apply online please use the 'apply' function, alternatively you may contact Khalis at 6510 7401
(EA: 94C3609/ R1551822 )