SEKISUI DIAGNOSTICS P.E.I. INC. Regulatory Affairs Associate Contract in Charlottetown, PE

Overview

SEKISUI DIAGNOSTICS P.E.I. INC.

Branch Charlottetown PE CA

Position:
Regulatory Affairs Associate
Location:
Charlottetown, PE

Work closely with marketing to assemble information required to support other international registrations including requests for FDA Certificates to Foreign…

REGULATORY AFFAIRS OFFICER I – 1 Year Term Contract
(Charlottetown, PEI)

Sekisui Diagnostics P.E.I. Inc . is a leading manufacturer focused on bringing general and specialty chemistry reagents and point-of-care diagnostic tests to market. Our company requires a highly motivated individual to join our growing team. This is a one year temporary, full-time position.

The Regulatory Affairs Associate I will:

• Work with a multi-disciplinary team, coordinate submission preparation of 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 Clinical Chemistry 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.
• Assist in preparing and maintaining 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. Assist in the research of regulatory information and data to support new product strategies.
• Must be willing to work/live in Charlottetown PEI.

The successful applicant will have:

• Bachelor’s Degree in Science (Biology, Biochemistry, Chemistry, Medical Technology preferred) or related discipline.
• Industry experience in IVD devices, Medical Devices, or Pharmaceuticals.
• Experience with FDA regulations (21 CFR 820) required.
• Experience ISO 13485, Health Canada Medical Device regulations, EU IVD Directive.
• Organization skills and be willing to learn and operate as a team player
• Outstanding oral and written communication skills.

Sekisui Diagnostics P.E.I. Inc. offers a competitive salary. We thank all applicants for their interest.

By applying to this position you are confirming you possess either a Canadian citizenship, permanent resident status or work permit.