Regulatory Affairs Specialist
Will perform some or all of the following:
- Help Regulatory Affairs (RA) Lead to obtain and compile documents and information to support In Vitro Diagnostics Regulation (IVDR) requirements within the Technical Documentation Files (TDF's)
- Work on problems of diverse scope and provide schedules/plans for programs
- Communicate with internal department functions to obtain required information to support the TDF's
- Manage activities related to IVDR projects / products
- Establish and maintain direction of the clinical development through strategic planning with limited direction from supervisor
- Prepare document packages for 510(k) premarket notifications, Health Canada licenses and EU Technical Files
- Work closely with marketing to assemble information required to support other international registrations including requests for Food and Drug administration (FDA) Certificates to Foreign Government and Declarations of Conformity
- Maintain well organized regulatory files for assigned product line by monitoring and tracking information, assuring accurate recordkeeping and preparing documents
- Assess product and process changes for cleared 510(k) products and assist in determining if changes require updates or new product registrations
- Perform routine reviews of IVD product labeling, including promotional materials, as assigned; identify label changes that require higher level regulatory review
- Prepare and maintain regulatory department files for establishment registrations and listings, product registrations, Medical Device Reports (MDR's) and product recalls
- Compile, organize, and transcribe documentation for regulatory submissions, license renewals, and annual registration
- Research regulatory information and data to support new product strategies
- Create and maintain regulatory files and archives, as assigned
- Stay abreast of regulatory procedures and changes
- Demonstrate commitment to the development, implementation and effectiveness of Sekisui Diagnostics' Quality Management System per ISO, FDA, and other regulatory agencies
- Understand and is aware of the quality consequences which may occur from the improper performance of their specific job
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices
- Carry out duties in compliance with established business policies
- Additional duties, as assigned
Organizational Impact / Education / Experience:
- Bachelor's Degree in Science (Biology, Biochemistry, Chemistry, Medical Technology preferred) or related discipline.
- Relevant industry experience in IVD devices, Medical Devices, or Pharmaceuticals.
Skills / Pre-requisites:
- Experience with FDA regulations (21 CFR 820) required
- ISO 13485, Health Canada Medical Device regulations, EU IVD Directive experience a plus
- Must be organized and detail oriented
- Experience participating on multi-functional teams
- Outstanding oral and written communication skills required
- No specific training experience required.
Sthree US is acting as an Employment Business in relation to this vacancy.