MAIN JOB RESPONSIBILITIES Assist current regulatory staff with FDA and international regulatory submissions including 510(k), PMA, design dossiers, technical files, and other registrations, as needed for Class I, II and III medical devices. This may include:
o Coordination of essential documents/tools for regulatory submissions (i.e. prepare the required amount of copies, labels required for cover labels and attachments, etc.).
o Quality check submissions for compliance with applicable regulations.
o Preparation and maintenance of annual renewals of Establishment Registrations, State Manufacturing licenses, Device Listing, and other pertinent domestic and international licensing.
o Compile information necessary for periodic reports for Regulatory filings.
Review and interpret regulatory rules and ensure that they are included in company/department practices/procedures.
Review complex reports, validations, etc. for scientific merit and regulatory appropriateness.
Review/Edit communications; including memos, correspondence, SOPs and presentations.
Review/Prepare Standard Operating Procedures (SOPs).
Maintain a matrix for international country regulations for product submissions.
Assess/Index/Organize regulatory library.
o Compliance to Regulatory Filings.
o Verification of support related to that the intended use and claims.
o Determination of regulatory submission requirements according to domestic and international regulations.
Develop/review procedures for compliance with the intent of EN ISO 13485, and 21 CFR 820
Participate in/Support Health Authority Inspections
Review materials prior to presentation to investigators/ or response submissions
Perform or participate in the following activities:
o Risk analysis
o Root cause analysis
Participate on remediation teams.
EDUCATION & TRAINING B.A. /B.S. degree required, preferably in Regulatory Science related field.
EXPERIENCE
One or two years of work experience preferred.
SKILLS
Thorough understanding of FDA and international regulations.
Strong working knowledge of medical devices regulations and terminologies.
Excellent written and oral communication, and technical writing and editing skills.
Ability to write clear, understandable technical documentation.
Skilled at analyzing and summarizing data.
Proficient with Microsoft Office.
Ability to follow written and verbal directions with a high level of accuracy.
Attention to detail.
Ability to work in a team setting.