Medical Device Regulatory Affairs Specialist

Job Title

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Company

About The Company

Job Brief

Regulatory Affairs Specialist

Key Responsibilities

• Ensure compliance of all medical devices with national and international regulatory requirements and standards.
• Prepare, compile, and submit regulatory submissions such as 510(k), PMA, and market registrations for global markets.
• Liaise with regulatory authorities (e.g., FDA, CDSCO) to address queries and facilitate product approvals.
• Monitor, interpret, and communicate changes in medical device regulations and assess their impact on the organization.
• Provide regulatory guidance, support, and training to cross-functional teams (R&D, QA/RA, Product Development, etc.).
• Develop and implement regulatory strategies to enable new product development and market expansion.
• Maintain accurate, organized, and up-to-date documentation for regulatory compliance and audits.
• Collaborate effectively with channel partners and documentation specialists to ensure regulatory alignment across functions.
  

Requirements

• Bachelor’s degree in Biomedical Engineering, Electronics & Communication, or a related discipline.
• 3–4 years’ experience in regulatory affairs for medical devices.
• Comprehensive knowledge of domestic and international medical device regulations (e.g., FDA, EU MDR, ISO 13485, CDSCO).
• Excellent verbal and written communication skills.
• Strong attention to detail with analytical thinking and problem-solving abilities.
• Ability to work effectively in a collaborative, cross-functional team environment.
  

Preferred Qualifications

• Regulatory Affairs Certification (RAC).
• Experience working with Class II or III medical devices.
• Familiarity with quality systems such as ISO 13485 and FDA QSR.
  

Benefits And Perks

• Competitive salary and performance-based incentives
• Opportunities for professional development and regulatory training
• Supportive work environment with experienced industry professionals
• Exposure to international regulatory processes
• Health and wellness benefits