Regulatory Affairs

18 hours ago


Surat, India Concept Medical Full time

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. 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. 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. 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. Professional certification in regulatory affairs (RAC).



  • Surat, India Concept Medical 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...


  • Surat, India Concept Medical 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...


  • surat, India Concept Medical 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...

  • Regulatory Affairs

    5 days ago


    Surat, Gujarat, India SALVAVIDAS PHARMACEUTICAL Full time

    **Roles & Responsibility**: - Prepare, compile, and submit regulatory documents to health authorities (e.g., FDA, EMA, MOH) for product approvals, renewals, and variations. - Ensure all submissions are accurate, complete, and submitted in a timely manner. - Ensure compliance with all local, national, and international regulations and standards for...


  • Surat, India Concept Medical 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...


  • Surat, India Concept Medical 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...


  • Surat, India Concept Medical 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...


  • Surat, India Concept Medical 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...


  • Surat, India Concept Medical Full time

    Job Description 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...


  • Sachin, Surat, Gujarat, India Globela Laboratories Pvt Ltd Full time

    **Name of the Department** Regulatory Affairs **Designation** Regulatory Affairs Executive **Qualification**:M. Pharm **Reporting to** Head - Regulatory Affairs **Primary Responsibilities**: **1.** Provide responses to the regulatory agencies regarding Product information or issues. **2.** Review and compilation of the dossiers data. **3.** To...