Job Position: QA/RA Executive - Manager
Location: Rabale (Navi Mumbai)
Company: XcelLance Medical Technologies Pvt. Ltd.
There are vacancies for junior as well as senior level.
Freshers with biomedical or biotechnology engineering can also apply.
Requirements:
1. Experienced candidate should have experience in Medical devices of surgical equipments.
2. Experience of ISO 13485:2016 and preferably USFDA audit.
3. Candidate should have both Quality Assurance and Regulatory Affairs Experience.
Qualification: BE Biomedical/Biotechnology (Preferable), Bsc/Msc/Bpharma/Mpharma
Job Description:
1. Implementation of ISO 13485 Quality Management
System and maintaining related documentation for the
periodic audits.
2. Fulfilling regulatory requirements for Registration of
Medical Devices in various countries.
3. Efficient Implementation and management of ISO 13485, US FDA - 21 CFR, MDD 93/42/EEC, MDR 2017/745, CER, ISO 14971.
4. Preparation of Technical File, Instruction Manual, Post
Market Surveillance and Clinical Evaluation Report for
medical devices.
5. Ensure appropriate submission of license.
7. candidate should be fluent in English.
Kindly share your CV on hr@shalya.in
Location: Rabale (Navi Mumbai)
Company: XcelLance Medical Technologies Pvt. Ltd.
There are vacancies for junior as well as senior level.
Freshers with biomedical or biotechnology engineering can also apply.
Requirements:
1. Experienced candidate should have experience in Medical devices of surgical equipments.
2. Experience of ISO 13485:2016 and preferably USFDA audit.
3. Candidate should have both Quality Assurance and Regulatory Affairs Experience.
Qualification: BE Biomedical/Biotechnology (Preferable), Bsc/Msc/Bpharma/Mpharma
Job Description:
1. Implementation of ISO 13485 Quality Management
System and maintaining related documentation for the
periodic audits.
2. Fulfilling regulatory requirements for Registration of
Medical Devices in various countries.
3. Efficient Implementation and management of ISO 13485, US FDA - 21 CFR, MDD 93/42/EEC, MDR 2017/745, CER, ISO 14971.
4. Preparation of Technical File, Instruction Manual, Post
Market Surveillance and Clinical Evaluation Report for
medical devices.
5. Ensure appropriate submission of license.
7. candidate should be fluent in English.
Kindly share your CV on hr@shalya.in
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