Medical Device Compliance Manager

2 weeks ago


Bengaluru, Karnataka, India Dozee Full time

**Job Overview:**

We are Dozee, a leading company in the medical device industry, and we are looking for an experienced Medical Device Compliance Manager to join our team.

The ideal candidate will have a strong background in medical device regulations, experience with international submissions, and excellent analytical skills.

About the Role:

This is a full-time position that requires working closely with cross-functional teams to ensure quality and regulatory requirements are met.

The successful candidate will have a proven track record of managing regulatory affairs, leading audit and inspection preparations, and coordinating CAPA meetings.

Key Responsibilities:

  1. Develop and implement regulatory strategies to ensure compliance with local and international regulations.
  2. Manage regulatory submissions, including dossier preparation and device master file development.
  3. Lead audit and inspection preparations, including resolution of findings with stakeholders.
  4. Coordinate CAPA meetings and provide assistance to corrective action owners.

Requirements:

  • Minimum 3-5 years of experience in Medical Device Regulation.
  • Experience with international medical device regulatory approvals and submissions.
  • Demonstrated knowledge of US FDA, EU MDR, ISO 13485 Quality Management System, and ISO 14971 Risk Management for Medical Devices.

Salary: $80,000 - $110,000 per year, depending on experience.

Benefits:

  • A competitive salary package.
  • Ongoing training and professional development opportunities.
  • A dynamic and supportive work environment.


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