1. Product Registration & Certification
- Responsible in preparing the documentation as applicable for the product registration and the certifications and submitting in a timely manner.
- Maintain Regulatory Files and update regulatory authorizations such as CE,510K,Canadian medical device license
2. Regulatory Audits -Internal and External Audit
- Lead a role in Internal & External audits.
Timely conduct the internal audit and release Internal audit reports
3. QMS-Maintenance
- Compile and maintain regulatory documentation databases as per ISO 13485:2016 and other applicable regulatory requirements
- Identify the related and required documents in line with processes ensuring quality standards.
4. Change Management
- Release and approve document change order (DCO) and release documents on time and maintain a log.
- Ensure and supervise the Engineering change requests, compile, issue and maintain the log.
5. New Product Development
- Prepare and release the documentation of the new product within the timeline.
6. Reporting
Timely preparation and submission of MIS report on a daily/weekly/monthly basis.
Specific Skill
- Btech Electronics ,Biomed, Biotech or related industry
- Proficiency in English communication.
- Strong initiative skills, working both independently and as part of a team.
- Proactive high performance oriented skills
- Problem-solving skills.
- Manage multiple projects and deadlines
- Computer proficiency.
- Good knowledge of current Regulatory / GMP requirements (US FDA, EU MDR, MDSAP)