Regulatory Affairs Specialist
14 hours ago
We are seeking a dedicated and knowledgeable Regulatory Specialist to join our team. This role is responsible for ensuring our medical devices meet local and international regulatory standards.
The ideal candidate will have extensive knowledge of CDSCO, ISO, FDA, and other regulatory requirements, ensuring the highest standards of safety and efficacy for our products.
- Develop regulatory strategies for new/existing products.
- Ensure compliance with local/international regulations (CDSCO, ISO, FDA).
- Prepare and submit regulatory submissions.
- Monitor regulatory developments and adjust strategies.
- Liaise with regulatory bodies and internal teams for compliance.
- Conduct audits and maintain up-to-date knowledge of regulatory requirements.
To be successful in this role, you should have:
Qualifications- Bachelor's degree in a scientific discipline.
- 2 to 3 years' experience in regulatory affairs within the medical device industry.
- Experience with regulatory submissions and medical device development.
- Excellent communication, organizational, and project management skills.
A professional certification in regulatory affairs (RAC) would be an asset to your application.
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