Regulatory Affairs Executive

Intense Medical & Dental System Pvt. Ltd.

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

  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