Regulatory Affairs Specialist
Performs the coordination and preparation of document packages for regulatory submissions for new and mature IVD products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of Sekisui Diagnostics as well as internal audits and inspections. Position may be located in either PEI, Canada or Lexington, MA, USA, with preference to PEI candidates.
May perform some or all of the following:
Establish and maintain direction of the clinical development through strategic planning with limited direction from supervisor
Prepare document packages for 510k 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 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
Prepares and maintains regulatory department files for establishment registrations and listings, product registrations, MDR reports and product recalls
Compile, organize, and transcribe documentation for regulatory submissions, license renewals, and annual registrations. Researches regulatory information and data to support new product strategies.
Create and maintain regulatory files and archives, as assigned
Stays abreast of regulatory procedures and changes
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.
Must be organized
Experience participating on multi-functional teams
Outstanding oral and written communication skills required
Skills / Pre-requisites:
Experience with FDA regulations (21 CFR 820) required
ISO 13485, Health Canada Medical Device regulations, EU IVD Directive experience a plus