Duration; 3 months
Location; San Diego, CA
Need prior experience in a medical device industry (not call center).
Clinical is very important too-have them check technicians and nursing-experience with catheters.
Ideally I am looking for someone who has prior experience in a medical device industry and has already done things noted in the Responsibilities section.
Here is a list of keywords for them to search by: Complaint Analyst Post Market 820.198 Part 820 Post Market Surveillance MDR Vigilance EU MDR Adverse Event Failure Investigation Complaint investigator or investigation Catheter Cath Lab OBL
This is a Complaints Investigator position for IGT Devices; part of the Philip Image Guided Therapy business group. In this role, you have the opportunity to work with cutting-edge medical device product lines!
To succeed in this role, we look for the minimum following skills and experience:
o Bachelor's degree
o Prior complaint handling experience in a medical device industry
o Knowledge of FDA/QSR requirement & quality systems in Pharma and/or Medical device experience required (i.e. 21 CFR Part 820, Quality System Regulations , 21 CFR Part 803, Medical Device Reporting, The Privacy Rule, HIPAA, ISO 13485)
o Demonstrated experience meeting performance requirements
o Solid experience with use of word processing, spreadsheet, database and presentation applications
o Good organizational skills a must. Effective communication skills needed to provide clear and concise information to team members.
As a part of our team, you may be responsible for any of the following:
o Day-to-day complaint management of quality, technical and adverse event complaint records, including intake, follow up, triage and entry, in accordance with local and international regulations, guidelines, and applicable directives.
o Receipt of initial complaint from any source (external and internal) and ensuring all information/data is accurately captured at point of contact. You may triage calls from various sources for complaints, request for refund, request for replacement product and request for credit.
o Maintaining an understanding of information/data required to be collected for technical and adverse events/ reportable complaints to ensure compliance with regulations and directives.
o Reviewing complaint data, assessing against reporting requirements and escalating for additional potential safety evaluation. May compose and/or submit Medical Device Reports.
o Performing intake / follow up / data entry activities and attaching corresponding source documents in a timely manner in a high volume, fast paced setting per requirements and directives.
o Reviewing record documentation and follow-up activities for completeness and timeliness.
o Closing files according to established guidelines to meet required timelines.
o Maintaining a working knowledge of company policies and procedures, departmental processes, and associated procedures and work instructions, Philips IGT devices for IFUs, Manuals, Promotional Material; coronary and therapeutic procedures.
o Informing management of potential safety issues, emerging trends and/or concerns