Regulatory Affairs Specialist
1 day ago
**Job Summary:**
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Dozee. This role will be responsible for ensuring compliance with local and international regulations, including US FDA, EU MDR, and ISO 13485.
The ideal candidate will have a strong understanding of 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.
Responsibilities:
- Plan, establish, and maintain a Quality Management System in accordance with EN ISO 13485.
- Implement regulatory strategies for maintaining compliance with established standards like IEC 60601, IEC 62304, US FDA, and CE Marking.
- Prepare dossiers and device master files for regulatory submissions.
- Follow the Medical Device Act by CDSCO and other relevant regulations related to products developed.
- Work with different teams to set up Quality policies and standards.
- Ensure all established quality and delivery commitments are met.
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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