Regulatory Compliance Specialist

2 days ago


Aligarh, Uttar Pradesh, India Sol-Millennium Medical Group Full time
Job Title:

Quality Assurance Manager - Sol-Millennium Medical Group

Job Summary:

We are seeking a highly skilled Quality Assurance Manager to join our team at Sol-Millennium Medical Group. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining a state of control for our quality management system.

Key Responsibilities:
  • Regulatory Compliance: Ensure compliance with international regulatory requirements, including ISO 13485, MDSAP, EU Medical Device Directives, and EU Medical Device Regulations.
  • Complaint Handling: Timely report complaints, support complaint evaluation and investigation, and review quality records.
  • Quality Assurance: Ensure compliance with ISO 13485 and other applicable regulations, establish and maintain quality management system procedures.
Requirements:
  • Qualifications: Diploma or certificate in law, medicine, pharmacy, engineering, or a relevant scientific discipline, and at least one year of professional experience in regulatory affairs or quality management systems.
  • Skills: Good working knowledge of Microsoft Office, experience in auditing, and knowledge of ISO 13485 and ISO 9001 standards.


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