QAE & REGULATORY AFFAIRS ASSOCIATE – PHARMACEUTICALS & MEDICAL DEVICES

Our company is a specialty medical device, cell-tissue-organs, and pharmaceutical importer and distributor. We are committed to providing exceptional service and brand awareness to thousands of hospitals, dental and oral surgery clinics that we serve in Canada, the United States and around the world. Our company represents leading brands in their respective categories.

The QA & RA Associate position is a GMP role responsible for a wide variety of Quality Assurance and Regulatory Affairs activities related to drugs, MDs, CTOs and NHPs. In addition, the QA & RA Associate will communicate with vendors, prepare documentation and processes, contribute to drugs or MD submissions, and maintain all documentation and records.

QUALIFICATIONS

• Bachelor’s degree in science or a related field (e.g., Biology, Chemistry, Biochemistry, Biotechnology, Kinesiology, Pharmacology, Pharmacy, Biomedical Sciences, etc.)
• 4+ years of experience in pharmaceuticals and/or medical devices (MD) in a QA role
• Meet all Health Canada requirements to be approved as AQPIC (Narcotics activity)
• Skilled on writing GMP technical documents
• Experience with regulations of drugs and medical devices
• Knowledge of Health Canada drug regulations, as well as US FDA MD regulations
• Strong knowledge of Health Canada requirements for Good Manufacturing Practices (GMP) for drugs
• Familiar with Health Canada requirements for Quality Management Systems (QMS) for MDs
• Knowledgeable in FDA requirements for Quality Management Systems for MDs and HCTPs
• Knowledgeable, thru education and /or professional experience in drugs, pharmacovigilance, and MDs problem reporting
• Strong computer knowledge, including MS office (Word, Excel), Adobe, and network environments
  

  - SAP experience is an asset

• Ensure compliance with Health Canada and FDA regulations.
• Maintain documentation for Drugs, Medical Devices (MDs), CTOs, and NHPs.