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Regulatory Affairs Associate
Eingestellt von SEKISUI DIAGNOSTICS P.E.I. INC.
Gesuchte Skills: Support, Marketing
Projektbeschreibung
SEKISUI DIAGNOSTICS P.E.I. INC. is a leading manufacturer of general and specialty clinical chemistry assays used in hospitals around the world. Our company requires a highly motivated individual to join our growing team.
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.
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.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Marketing/Vertrieb, Sonstiges