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18/05 Asha
Manager at Proassert

Views:331 Applications:43 Rec. Actions:Recruiter Actions:11

Lead Consultant - Process & Quality - Medical Device - Contractual (6-10 yrs)

Bangalore/Gurgaon/Gurugram Job Code: 23465

Contract - 12 Months

- 6-10 years of related work experience

- Minimum 3 years in medical device.

- Bachelor of Science Degree in technical, engineering, and/or a life science discipline.

- ISO 9001:2015, ISO 13485:2016 certified auditor

- Regulatory training and certificates.

- Ability to execute assignments independently as assigned. Must possess strong organizational skills.

- Must possess strong written and verbal communication skills.

- Must possess demonstrated ability to handle multiple priorities simultaneously. Proficient in Microsoft Office Products.

- Working and up-to-date Knowledge of 21 CFR 820, EU MDD/MDR/MDSAP, ISO 13485:2016, and ISO 14971, ISO/IEC 62304, Usability (HFE) - IEC 62366 for Medical Devices.

- Experience of PMA submissions, 510(K) submissions

- Demonstrate high level knowledge of country regulations and regulatory guidelines

- Good documentation and communication skill

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