Regulatory Affairs Executive

Key Responsibilities:

�� Ensure medical devices comply with all applicable national and international regulatory requirements and standards

�� Prepare and submit regulatory submissions, including 510(k), PMA, and other global market registrations

�� Communicate with regulatory authorities (such as the FDA, CDSCO) to handle queries and support approval processes

�� Monitor and interpret changes in medical device regulations and assess their impact on the company

�� Provide regulatory guidance and training to cross-functional teams including R&D, QA/RA, and Product Development

�� Develop and implement regulatory strategies to support new product development and market expansion

�� Maintain organized, up-to-date documentation to demonstrate compliance and support audits

�� Collaborate with channel partners and internal documentation specialists to ensure consistent regulatory alignment

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Requirements:

�� Bachelor��s degree in Biomedical Engineering, or electronic commination. or a related discipline

�� 3 - 4 years of experience in medical device regulatory affairs

�� Strong knowledge of domestic and international medical device regulations (FDA, EU MDR, ISO , CDSCO, etc.)

�� Excellent verbal and written communication skills

�� High attention to detail, analytical thinking, and problem-solving ability

�� Experience working collaboratively across multiple tea

• Experience

  10 - 11 Years

• No. of Openings

  1

• Education

  Doctorate/PhD (Ph.D/Doctorate)

• Role

  Regulatory Affairs Executive

• Industry Type

  Pharma / BioTech / Clinical Research

• Gender

  Male

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office