The Senior Regulatory and Quality Affairs is responsible for strategizing, developing, implementing and completing projects and other activities associated with domestic and international regulatory and quality affairs.
Strategize and prepare U.S. domestic and O.U.S. international regulatory filings such as 510(k), IDE, and Technical File submissions, including subsequent revisions, supplements and amendments.
Assist worldwide distributors with product registration and renewals.
Timely compilation of materials for worldwide license renewals, updates and registrations.
Maintain regulatory files/database and chronologies in good order.
Maintains on-going surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.
Review international shipment requests to ensure regulatory requirements and import/export regulations are met.
Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
Maintain the External Standards database
Represent regulatory and quality function on project teams and provide input on regulatory strategy.
Review and approve advertising and promotion materials in compliance with FDA regulations and guidelines.
Product Labeling generation per regulations/standards and User Manual creation assistance
Review and approve Engineering Change Requests, CAPAs, and NCRs.
File any serious adverse events (MDR, Vigilance reports) worldwide
Co-ordinate and file all actions with respect to recalls, field actions worldwide
Support internal and external audits as needed.
Assists or participates in the implementation of new product design assurance: Risk Management (per EN ISO 14971), Usability (per EN 62366-1), electrical safety testing (per EN ISO 60601-1 and 60601-1-2) software and hardware design verification and validation (per EN 62304 and other standards).
Participates in design reviews.
Bachelor's degree or higher in a relevant technical or scientific field is required.
4+ years of experience in regulatory submissions required.
3+ years of experience coordinating/filing recalls, corrections and removals
Experience in direct communication with regulatory agencies.
Prior experience as a project leader with strong project management skills.