Post Market Surveillance

Post Market Surveillance
Location Andover MA
Duration 6 months contract to start with
 
Experience: Minimum 8 years of professional experience in a medically regulated and technical environment. 
 Education: Bachelor's /Master's degree or equivalent. Demonstrated capability and experience in role. Clinical nursing experience preferred. 
 Handle the receipt, processing, and monitoring of requests from Competent Authorities (CA), Notified Bodies and other regulatory agencies and external customers who request additional information related to complaints and field actions. 
 Develop professional expertise, apply company policies and procedures to resolve a variety of issues. 
 Interface and collaborate with cross-functional personnel to facilitate investigations and responses in accordance with written procedures and global reporting requirements. 
 Support Q&R Management and BIUs by providing high quality project completion and deliverables in support of customer, business, and regulatory requirements/metrics. 
 Complete and maintain all training requirements. 
 Provide clinical consultation to businesses as required. 
 Apply knowledge of device regulatory requirements in order to support the Post Market Clinical and Complaint Surveillance reporting process 
 Possess excellent written and verbal communication skills. Demonstrate strong results orientation. 
 Leverage complaint investigation content to generate written responses for complaint related CA requests. 
 Perform queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints. 
 Review and comply with the all applicable company policies and procedures, local, state, and federal laws and regulations. 
 Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001. 
 Proficiency using office tools, and various other computer software applications.

Thanks & Regards, 
Imran (Emu) Shikalgar 
APN Software Services, Inc 
39899 Balentine Drive, Suite 385, Newark, CA 94560 
510-402-4704 (Voice & Text) 
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com 
linkedin.com/in/imranshikalgar

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