Medical Device Complaint, Lead
Description
- Leads the daily activities of the complaints department.
- Maintains QMS documentation required for complaint processing compliance with 21 CFR part 820.198 and MDSAP program.
- Organizes reporting of department operations to track department status.
- Files FDA Medical Device Reporting (MDR) and Health Canada incident reports.
- Evaluates event(s) to determine if it qualifies as a complaint.
- Maintains and completes complaint files for all customer complaints according to procedures.
- Assesses complaint information provided; conducts additional investigations and escalates complaint to appropriate parties as needed.
- Compiles adverse event investigation information; summarizes investigation, production analysis, imaging review, instructions for use (IFU), and other relevant labeling and/or training materials; formulates conclusions.
- Interfaces with customers and collaborates with various departments and management.
- Manages customer relationships and expectations during course of complaint investigation.
- Serves as resource for team members.
- Serves as subject matter expert (SME) of Quality Systems for complaint handling and regulatory reporting.
- Monitors complaints regulatory reporting requirements to ensure timeliness of submissions.
- Evaluates complaints for adverse event reporting as applicable.
- Verifies comprehensive content of draft MDR reports prior to submission of Form 3500A to FDA.
- Verifies decisions for "Vigilance report not required" and “MDR report not required” determinations.
- Closes complaint files when necessary.
- Reviews potential reportable events to determine if regulatory filings are required.
- Submits Regulatory Reports for US and OUS.
- Ensures compliance with all federal and international regulations applicable to manufactured medical devices.
- Coordinates escalation to Medical Reviewer(s) for decisions regarding potential for serious injuries based on assessed risks.
- Escalates complaints when new failure modes are encountered.
- Maintains awareness of new products and government regulations and requirements.
- Documents and completes complaints in timely manner.
- Prepares and submits final customer correspondence as required.
- Performs other related duties and projects as business needs require at direction of management.
- Bachelor’s degree in science, engineering, or equivalent relevant experience preferred.
- Minimum five (5) years of experience within complaint handling department or equivalent.
- Minimum one (1) year of experience as a Lead, preferred.
- Advanced medical device experience involving medical device complaint files, inspections and, quality records required.
- Advanced understanding and interpretation of domestic and international complaint handling and reporting requirements required.
Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell!
In addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more!
Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at recruitment@glidewelldental.com. Please indicate the specifics of the assistance needed.
Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form.