Vigilance Specialists
AI Summary
Associate MDR/Vigilance Specialists intake, document, and investigate complaints for legacy Neuromodulation products, ensuring Medical Device Reporting and compliance with regulations.
About this role
Vigilance Specialists
Collabera is ranked amongst the top 10 Information Technology (IT) staffing firms in the U.S., with more than $550 million in sales revenue and a global presence that represents approximately 12,000+ professionals across North America (U.S., Canada), Asia Pacific (India, Philippines, Singapore, Malaysia) and the United Kingdom. We support our clients with a strong recruitment model and a sincere commitment to their success, which is why more than 75% of our clients rank us amongst their top three staffing suppliers.
Associate MDR/Vigilance Specialists are responsible for theintake, documentation, Medical Device Reporting, and investigation of complaintsfor legacy Neuromodulation products in accordance with applicable internalprocedures (work instructions) and external requirements (regulations orguidance from any and all regulatory bodies).
Position Responsibilities:
Receive and assess product comments to determine need for complaint handlingrecord.
Document required information in Global Complaint Handling (GCH).
Assess complaint file for missing required information. If information ismissing, initiate attempts to gather information. Steps may include contacting:<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />
Health Care Providers <?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />
Communicate with outside parties in a professional and customer-focused mannerthat is in following with our Mission and enhances the Medtronic brand.
Qualifications
• 0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation.
Additional Information
To know more and apply feel free to contact:
Sagar Rathore
Sagar.rathore(at)collabera.com
630-485-2166
Skills
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