Regulatory Affairs Associate

4 weeks ago

Surat, Gujarat, 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 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:

- 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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