Regulatory Affairs Specialist
2주전에
We are seeking a skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing effective strategies to meet business needs.
About the Role:- Develop and implement regulatory strategies to ensure compliance with local regulations
- Manage and execute regulatory submissions to local health authorities
- Compile and submit reports to local health authorities as required
- Review and manage procedures related to regulatory activities and documentation
- Interact with local health authorities during review process
- Develop and maintain knowledge of local regulations and guidelines
- Identify and mitigate potential risks associated with non-compliance
- Collaborate with cross-functional teams to ensure regulatory requirements are met
- Provide training and support to colleagues on regulatory matters
- Bachelor's degree in Science, Medical Technology or related field
- Minimum 5 years of experience in medical device regulatory affairs
- Related experience and knowledge in Quality Management System is advantageous
We offer a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.
This is an exciting opportunity to join a leading organization and make a meaningful contribution to our success.
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