
Regulatory Compliance Expert
4 days ago
About us, we are at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare drives us to provide best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team to further our mission of saving lives and improving patient care.
We are seeking a dedicated Regulatory Specialist to ensure our medical devices meet regulatory standards. The ideal candidate will have extensive knowledge of regulatory requirements, ensuring the highest standards of safety and efficacy for our products.
Key responsibilities include:
- Developing regulatory strategies for new/existing products.
- Ensuring compliance with local/international regulations (CDSCO, ISO, FDA).
- Preparing and submitting regulatory submissions.
- Monitoring regulatory developments and adjusting strategies.
- Liaising with regulatory bodies and internal teams for compliance.
- Conducting audits and maintaining up-to-date knowledge of regulatory requirements.
Required qualifications:
- Bachelor's degree in a scientific discipline.
- 2 to 3 years' experience in regulatory affairs within the medical device industry.
- In-depth knowledge of CDSCO, ISO, FDA standards.
- Experience with regulatory submissions and medical device development.
- Excellent communication, organizational, and project management skills.
Preferred qualifications:
- Advanced degree (Master's/Ph.D.).
- Professional certification in regulatory affairs (RAC).
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