Occupation : Regulatory Affairs Manager
Job Description & Requirements
Your responsibilities include participating in all phases of the software development lifecycle with the ultimate goal of ensuring our organization meets all the applicable quality and healthcare regulations, such as those established by the Food and Drug Administration.
Some of the specific duties are listed below:
- Responsible for regulatory management and expansion
- Develop business, distributor management and pricing, especially throughout Asia
- Customer management includes sales follow up and demos presentation
- Supervise the completion and filing of paperwork with the appropriate agencies globally.
- Take full responsibility for the company’s QMS system.
- Create and evaluate compliance strategies for current and new.
- Implement internal organisational audits, handling the notarization of compliance reports, and creating and communicating organisational regulatory work processes.
- Stay abreast of new applicable laws and provide organizational management with updates on how the changes will affect the business.
- Excellent analytical abilities
- Strong communication skills
- Superb attention to details
- Strong self-motivation with the ability to deliver the occasional miracle
- Ability to fit in with an extremely international team of overachievers that love working and playing hard