Quality & Regulatory Affairs Executive

2 days ago

Hyderabad, India Monitra Health Full time

Job Summary:

We are seeking a Quality & Regulatory Affairs Executive. This role involves implementing and maintaining Quality Management Systems (QMS) and assisting in regulatory submissions to global authorities such as the US FDA, European Union (CE Mark), and CDSCO. The ideal candidate will collaborate with cross-functional teams to ensure compliance with regulatory standards, drive continuous improvement initiatives, and stay updated on global regulatory developments.


Responsibilities:


  • Assist in implementing and maintaining QMS per ISO 13485, 21 CFR Part 820, and CDSCO MDR requirements.
  • Conduct training sessions for cross-functional teams on QMS processes.
  • Manage QMS activities such as Change Control, Risk Management, Post-Market Surveillance, Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and Complaint Handling.
  • Support the creation and submission of regulatory documents for the US FDA (510(k)), European Union (CE Mark), and CDSCO.
  • Work with Product and Software teams to align processes with regulatory requirements.
  • Work closely with internal teams to ensure effective implementation of quality management system processes.
  • Provide guidance on regulatory requirements and their application in product development and operational workflows.
  • Ensure organizational compliance with updated standards and regulatory guidelines.


Preferred Qualifications:


  • Minimum of 2–3 years in Quality Management Systems (QMS) and Regulatory Affairs roles.
  • PG/B.Tech in Life Sciences, Biotechnology, or Biomedical Engineering.
  • Strong knowledge of standards like ISO 13485, ISO 14971, IEC 62304, and IEC 62366 is preferred.
  • Familiarity with regulatory pathways such as US FDA 510(k), EU MDR (CE Mark), and CDSCO MDR.
  • Analytical ability to interpret and apply regulatory standards effectively.
  • Proficient in writing reports and documentation, adhering to good documentation practices (GDP).
  • Proactive and passionate about Quality & Regulatory Affairs, with a drive to manage multiple processes and activities.
  • Excellent time management and multitasking abilities.
  • Strong interpersonal, listening, and communication skills to interact effectively with stakeholders.
  • Motivated self-starter with a proactive approach to problem-solving and customer service.
  • Commitment to upholding ethical standards and fostering a positive team environment


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