QARA + SaMD Specialist

Job Title : QARA + SaMD Specialist (Contract Role)

Company : Aegan Technologies

Locations : Pune | Chennai | Bangalore | Mumbai | Hyderabad

Experience : 3 to 10 Years

Join Within : 15 Days

Job Description :

Aegan Technologies is hiring experienced QARA + SaMD Specialists for a contract-based opportunity.

The ideal candidate will be responsible for managing regulatory strategies, ensuring compliance with global standards (FDA, EU MDR, ISO, IEC), and maintaining QMS and DHF documentation for software-based medical devices.

Key Responsibilities :

• Manage regulatory and quality processes for medical devices & SaMD.
• Ensure compliance with FDA QSR, ISO 13485, ISO 14971, IEC 62304, IEC 82304 & EU MDR.
• Prepare regulatory submissions like 510(k) and CE Mark.
• Maintain QMS and DHF documentation.
• Lead risk management and software validation activities.
• Collaborate with cross-functional teams to ensure compliance.

Skills Required :

Education :

Bachelor's degree in engineering, Life Sciences, Biomedical, or related field.

Interested Candidates Apply at [HIDDEN TEXT] / +91 9677254444

Skills Required

Med Device QARA, SaMD, DHF