Evaluate complaints to determine if MDR/MDV reports are required to FDA and Competent Authorities.
• Review reports of customer complaints and assess them for MDR / MDV reportability to FDA / Competent Authorities. • Ensure reports to FDA / Competent Authorities are completed within required timelines. • Submit initial and follow-up reports to device related Agencies as appropriate • Interact with device related Agencies on vigilance reports and incidents • Request information from the field to ensure all pertinent information is acquired to make adequate MDR/MDV decision. • Work with customers and sales forces to resolve complaint issues. • Work with Quality complaint-handling personnel. • Review and analyze data for trending purposes. • Work from verbal and/or written instructions. • Responsible for providing assistance in developing applicable policies and procedures. • Participate in process improvement and automation. • All other tasks and responsibilities as assigned by the Manager.
Qualifications/Work Experience
• 1 years experience as a Regulatory or Quality professional in a regulated manufacturing environment. Prefer experience with MDR/MDV reporting. • General knowledge of FDA and international medical device regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.) • Demonstrated ability to effectively work cross functionally with technical and non-technical personnel in other departments including Operations, Product Development and Marketing. • Demonstrated interpersonal, oral and written communication skills a must. • Demonstrated ability to exhibit a positive, energetic approach to teamwork. • Ability to advocate product excellence and quality. • Ability to read and interpret Engineering schematics / drawings / prints. • Demonstrated results orientation and ability to learn quickly. • Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines. • Computer proficiency with MS Office and the ability to learn Corporate systems • Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines.
Education and/or Special Training
Bachelor's Degree in Science, Engineering or related field of study preferred.
