Medical Device Compliance Manager
2 weeks ago
**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:
- Develop and implement regulatory strategies to ensure compliance with local and international regulations.
- Manage regulatory submissions, including dossier preparation and device master file development.
- Lead audit and inspection preparations, including resolution of findings with stakeholders.
- 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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