Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Our mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on quality, clinically relevant innovation, and simplicity. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community.

This role will collaborate across teams, influence strategic decisions and play a crucial role in shaping the future of medical technology.

Responsibilities of Senior Regulatory Affairs Specialist :

• Coordinate with Japan-based Engineering and Regulatory teams to ensure adequate documentation is generated to support regulatory filings in U.S., Canada and LATAM for Pentax branded endoscopes including 510(k) submissions.
• Represent PENTAX Medical in phone calls and meetings with the U.S. Food and Drug Administration and Health Canada.
• Participate in cross functional project teams for the development of new and revised Speech, Voice and Swallowing products including creation of Regulatory Assessments and review of design verification, validation protocols and reports and risk management documents and participation in project design review meetings.
• Work in partnership with manufacturing and QA / QC in designing and enhancing quality management systems to facilitate overall regulatory compliance.
• Reviews regulatory publications to keep apprised of new regulatory developments.
• Maintain list of regulatory and quality standards relevant to the design, development and manufacture of Speech, Voice and Swallowing products.
• Facilitate all FDA registration and listing related activities.
• Manage interactions with US Customs and Border Control and ensure compatibility and compliance with customs documentation requirements.
• Support International product registrations.

Requirements of Senior Regulatory Affairs Specialist :