Compliance Coordinator

3 days ago

Faridabad, India BSCIC Full time

**Location**: Faridabad

**Responsibility**: Directly under CE Supervision time to time guidance in the following fields**:

- Prepare Activity Code Approval Form, Evaluation of Competence of Certification Personnel, Interview Evaluation Form for Assessor, Technical Expert Review Qualification etc. for MD-QMS (ISO 13485), CE Marking & CDCSO Notified Body
- Maintain Assessor Witness Review Record, Assessor and Technical Expert Qualification Update, Review summary of competence & Agreements for MD-QMS, CE Marking & CDCSO Notified Body.
- Arrange Auditor Exam. Assessor and Technical Expert Qualification Update, Examination cum Calibration Record, and other records on time
- Management of Assessor or Expert files and Reports coordination & completion
- Customer Focus (Attend calls for queries & solve their issues with the co-ordination of staff)
- Review and update key medical/key medical documents on requirement basis
- Certificate Issue Check List and Corrective Active Request execution and follow ups.
- To amend BSCIC Procedures & Format as per new requirements and amendments in standards with MRO
- Verification & Validation of reports and certification for suitability.
- Follow up for new resources from Sales & Assessment department
- Monthly Reports Summary

**Competence Requirements**
- BE/B.Tech. in Electronic/Biotechnology/Biomedical, 1 years of work experience in medical device scheme (ISO 13485) as quality assurance preferably similar as scheduling or assessment management related to certification industry.
- Experience of dealing with CE Marking, CDCSO Notified Body requirements for medical devices.

**Note**:

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