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Concept Medical, a global leader in innovative medical devices for interventional cardiology and radiology, is hiring a Regulatory Affairs Associate in Surat, Gujarat. If you are passionate about compliance, regulatory submissions, and advancing patient care through innovative healthcare solutions, this role offers the perfect career opportunity.
🔑 Key Responsibilities
As a Regulatory Affairs Associate, you will:
- Develop and implement regulatory strategies for new and existing medical devices.
- Ensure compliance with CDSCO, ISO, FDA, and other international regulatory standards.
- Prepare and submit regulatory submissions and technical documentation.
- Monitor evolving regulatory requirements and adjust compliance strategies.
- Collaborate with regulatory authorities and internal cross-functional teams.
- Conduct audits and ensure continuous adherence to quality and safety standards.
🎓 Required Qualifications
- Bachelor’s degree in Pharma, Life Sciences, or a related scientific discipline.
- 2–3 years of experience in regulatory affairs within the medical device industry.
- Strong knowledge of CDSCO, ISO, FDA regulatory requirements.
- Hands-on experience in regulatory submissions.
- Excellent communication, organizational, and project management skills.
🌟 Preferred Qualifications
- Master’s degree or Ph.D. in a relevant field.
- RAC (Regulatory Affairs Certification) or equivalent professional certification.
💼 Benefits of Working at Concept Medical
- Competitive salary package.
- Exposure to global regulatory frameworks.
- Opportunity to work with cutting-edge medical device innovations.
- Professional growth and learning opportunities in an international environment.
📩 How to Apply
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