Quality & Regulatory Affairs Executive Hiring at Hyderabad, Monitra Health

Monitra Health, a leading organization in Hyderabad, Telangana, is seeking a dedicated Quality & Regulatory Affairs Executive. This role is perfect for professionals with expertise in Quality Management Systems (QMS) and regulatory submissions to global authorities.

---

About Monitra Health

Monitra Health is at the forefront of healthcare innovation, delivering solutions that meet global quality and regulatory standards. The company is committed to excellence and compliance, ensuring its products meet the highest safety and efficacy benchmarks.

---

Job Overview

Position: Quality & Regulatory Affairs Executive

Location: Hyderabad, Telangana

Vacancies: 1

This role involves implementing and maintaining Quality Management Systems (QMS), ensuring compliance with regulatory standards, and facilitating submissions to authorities such as the US FDA, European Union (CE Mark), and CDSCO.

---

Key Responsibilities

Quality Management Systems (QMS):

• Implement and maintain QMS in line with ISO 13485, 21 CFR Part 820, and CDSCO MDR requirements.
• Conduct training sessions on QMS processes for cross-functional teams.
• Manage QMS activities including:
  • Change Control
  • Risk Management
  • Post-Market Surveillance
  • Non-Conformance Reports (NCRs)
  • Corrective and Preventive Actions (CAPAs)
  • Complaint Handling

Regulatory Submissions:

• Prepare and submit regulatory documents for:
  • US FDA (510(k))
  • European Union (CE Mark)
  • CDSCO
• Work closely with product and software teams to align processes with regulatory requirements.

Compliance and Continuous Improvement:

• Ensure compliance with updated standards and regulatory guidelines.
• Drive continuous improvement initiatives within the organization.

---

Preferred Qualifications

Education:

• PG/B.Tech in Life Sciences, Biotechnology, or Biomedical Engineering.

Experience:

• 2–3 years in Quality Management Systems and Regulatory Affairs roles.

Skills and Knowledge:

• Strong knowledge of ISO 13485, ISO 14971, IEC 62304, and IEC 62366 standards.
• Familiarity with regulatory pathways including US FDA 510(k), EU MDR (CE Mark), and CDSCO MDR.
• Proficiency in documentation, with adherence to Good Documentation Practices (GDP).

---

How to Apply?

Step 1: Submit Your Application

Apply via LinkedIn by visiting this link.

Step 2: Selection Process

Shortlisted candidates will be contacted for further discussions and interviews.