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