Quality & Regulatory Specialist

e are looking for a QA/RA Specialist / Quality & Regulatory Specialist – Medical Devices to join our Quality & Regulatory Affairs team in Hyderabad. The ideal candidate will have hands-on experience in Quality Management Systems (QMS), ISO 13485 compliance, Regulatory submissions (FDA 510(k), CE Technical File), and medical device documentation.

If you have a strong background in medical device regulations, risk management, and technical documentation, this is a great opportunity to advance your career in a fast-growing MedTech environment.

Key Responsibilities:

• Implement and maintain Quality Management Systems (QMS) and manage CAPA, Internal Audits, and Nonconformance investigations.
• Prepare and review SOPs, Device Master Records (DMR), and Technical Files.
• Handle Regulatory Filings such as FDA 510(k), CE Technical Files, and CDSCO submissions.
• Support Labeling, UDI, and Post-Market Surveillance (PMS) activities.
• Liaise with Regulatory Authorities and Notified Bodies to maintain global compliance.

Required Skills

• Bachelor’s/Master’s in Biomedical Engineering, Biotechnology, Pharmacy, or related field.
• 2–6 years’ experience in QA/RA for Medical Devices.
• Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR, and EU MDR.
• Excellent communication, documentation, and audit management skills.

Job Type: Permanent

Pay: ₹50,619.83 - ₹70,000.00 per month

Work Location: In person