Regulatory Affairs Assistant K2M
THIS JOB HAS EXPIRED The purpose of this position is to assist in the development of a comprehensive regulatory affairs, complaint reporting and risk management program that complies with FDA regulations, ISO 13485 requirements, and other applicable regulatory bodies and standards.
Provide support for the preparation and submission of FDA regulatory applications.
Filing annual facility registrations for all K2M facilities and assuring they stay current
Monitor and update device listings
Assist with updating and maintaining product labeling
Assist with the preparation of clinical and regulatory summaries for product technical files for CE Marking
Assist in FDA inspections and ISO assessments.
Organize and maintain regulatory files and databases.
Provide support for the company?s PER and complaint filing systems.
Assure that all complaint files are processed in a timely manner and follow up analysis conducted as needed.
Gather data and prepare Management for the correspondences with the surgeons, sales force, engineers and hospitals to resolve and close complaint files.
Assist with reviewing all PER and complaint files - perform trend analysis when required.
Organize and trend PER and QA Hold data for the quarterly Management Review Meetings.
Assist in filing a MDR in a timely manner.
Develop an understanding of ISO 14971
Attend risk management team meetings
Bachelor?s degree in technical or science-related field
Training in FDA and ISO Quality System regulations and standards preferred.
2 years experience within a medical device manufacturing environment with direct quality system or regulatory working knowledge, preferred
Ability to interpret technical documents
Strong decision making skills
Strong written and communication skills
Ability to work independently, plan, and prioritize with little supervision
Medical Device experience with FDA Code of Federal Regulations ( CFR ) and GMP requirements, preferred.
Experience with ISO14971 and ISO13485, preferred
||751 Miller Drive, SE |
Leesburg, VA 20175
THIS JOB HAS EXPIRED