Regulatory Specialist @ Disha Skill Training

Job Description

Job Title: Regulatory Specialist Company: Concept Medical Location: Surat, Gujarat Job Type: Full-Time About Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the Netherlands to further our mission of saving lives and improving patient care. Job Summary: We are seeking a dedicated and knowledgeable Regulatory Specialist to ensure 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. Key Responsibilities: - 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. Required Qualifications: - Bachelors degree in a scientific discipline. - 4 to 5 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 (Masters/Ph.D.). - Professional certification in regulatory affairs (RAC

Employement Category:

Employement Type: Full time
Industry: Medical / Healthcare
Role Category: Field Sales ExecutiveSales / BD
Functional Area: Not Applicable
Role/Responsibilies: Regulatory Specialist

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Keyskills:   Regulatory Affairs ISO Regulatory Submissions Communication Skills Project Management CDSCO FDA Medical Device Development Organizational Skills