Regulatory Affairs Associate

Concept Medical is a leading developer and manufacturer of innovative medical devices specializing in interventional cardiology and radiology. Your role as a Regulatory Specialist will involve ensuring that our products comply with both local and international regulatory standards such as CDSCO, ISO, and FDA. Your expertise will be crucial in maintaining the highest levels of safety and efficacy for our stents and balloon catheters. Key Responsibilities: - Develop regulatory strategies for new and existing products to meet compliance requirements. - Ensure adherence to local and international regulations including CDSCO, ISO, and FDA. - Prepare and submit regulatory documentation and filings. - Stay informed about regulatory updates and make necessary adjustments to strategies. - Collaborate with regulatory agencies and internal teams to ensure compliance. - Conduct audits and stay current on regulatory standards and guidelines. Required Qualifications: - Bachelor's degree in a scientific discipline. - 2 to 3 years of experience in regulatory affairs within the medical device industry. - Profound understanding of CDSCO, ISO, and FDA standards. - Hands-on experience with regulatory submissions and medical device development. - Strong communication, organizational, and project management abilities. Preferred Qualifications: - Advanced degree (Masters/Ph.D.). - Professional certification in regulatory affairs (RAC). Join our dedicated team at Concept Medical and contribute to our mission of saving lives and enhancing patient care through innovative medical devices.,