Medical Device Regulatory Affairs Specialist

Job Title:

Medical Device Regulatory Affairs Specialist

Bhopal Location

Company:

Job Brief:

We are looking for a skilled Regulatory Affairs Specialist

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

Requirements:

• Bachelor’s degree in Biomedical Engineering, or B.E 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 13485, CDSCO, etc.)

• Excellent verbal and written communication skills

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

• Experience working collaboratively across multiple teams

Preferred Qualifications:

• Regulatory Affairs Certification (RAC)

• Experience with Class II or III medical devices

• Familiarity with quality systems (e.g., ISO 13485, FDA QSR)

• Contact No 9266682964