
Medical Device Compliance Specialist
3 days ago
We are seeking a highly motivated Medical Device Compliance Specialist to join our team at Sehat Medical Devices Pvt. Ltd.
The successful candidate will be responsible for ensuring that our products comply with relevant regulatory requirements and standards. They will work closely with cross-functional teams to develop and implement quality management systems, conduct internal audits, and manage external audits/inspections.
The ideal candidate will have a strong understanding of medical device regulations, such as ISO 13485, FDA QSR, and GMP requirements.
Main Responsibilities:
- Formulate and maintain a comprehensive Quality Management System (QMS) aligned with ISO 13485, GMP, and other relevant regulatory requirements.
- Conduct regular internal audits and manage external audits/inspections to ensure consistent compliance and swift resolution of non-conformances.
- Liaise with regulatory bodies to keep certifications, licenses, and approvals current.
Key Qualifications:
- Bachelor's or master's degree in a relevant field, such as Pharmacy, Microbiology, Biotechnology, Biomedical Engineering.
- Minimum 3 years of experience in quality control or quality assurance, with a strong background in medical device regulations.
- Proven track record of ensuring compliance with regulatory requirements and standards.
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