The client is a health solutions company that specializes in personalized cancer care and aims to provide treatment solutions based on the comprehensive analyses of patients’ genomic profile.  The company is impassioned by the tremendous forward momentum of cancer genomics and targeted treatment. Informed by cutting edge cancer research, the company is translating scientific knowledge into the well-being of the patients. Its mission is to bring precision cancer care to patients through the combination of next-generation sequencing (NGS) and up-to-date cancer knowledge base.  
The company is currently headquartered in Downtown Toronto, Ontario, Canada, and in Nanjing, Jiangsu, China.

This is an outstanding opportunity to join a fast-paced Biotech company in the exciting field of precision medicine. The experienced, highly motivated Manager, Regulatory Affairs will be responsible for regulatory product registration process through development of regulatory strategy and submission of materials to FDA, Health Canada or other international regulatory bodies for approval of Company’s NGS testing kit. This position requires close interaction with R&D team and manufacture partners for preparing document packages for appropriate regulatory bodies and ensures compliance with all requirements, and with regulatory authorities for product registrations
The position is a full-time position in Downtown Toronto.  

Responsibilities 

  • Responsible for product registrations of in vitro diagnostic medical devices in the US, Canada and other international markets;
  • Prepare, edit and review Product Technical Files/Dossiers for regulatory submissions;
  • Represent the regulatory affairs function on assigned cross-functional project teams;
  • Represent the company before regulatory authorities and biopharmaceutical partners on regulatory and technical matters, as needed;
  • Liaise with regulatory authorities in regulatory submissions, proposals, analysis and submission of change notifications and provide timely response to regulatory inspections;
  • Responsible for regulatory plan for new products (analytical and clinical validation), including clinical study compliance and submission requirements;
  • Participate in Design Reviews, including review of design documents, to ensure new products meet regulatory requirements;
  • Work with product managers/marketing on regulatory strategy for submissions, product configurations and customer-facing documents review;
  • Maintain regulatory activities including updating the technical files, regulatory log files and post market regulatory activities such as post market surveillance, health hazard evaluation, medical device reporting and recall;
  • Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the discipline as relevant to assigned projects, and update upper management on regulatory changes;
  • Provide and conduct training to employees on company’s quality system and regulations;
  • Work with Manufacturing/QC/Design Transfer/Supply Chain on Non-Conformance closure, CAPA and continuous improvement activities related to regulatory activities.
  • Other duties as assigned.

Requirements

  • Master’s degree in life sciences, biotechnology or related major,
  • 3+ years of professional experience in medical device, biotechnology, life science or healthcare regulatory affairs,
  • Regulatory compliance knowledge of FDA and/or Health Canada IVD requirements and understanding of validation design typical for IVD submissions,
  • Knowledge of ISO 13485, FDA 21CFR part 820,
  • Knowledge of clinical data interpretation,
  • Familiarity with device design control process and regulatory role in process,
  • Direct work experience in writing and submitting pre-submission, 510k and PMA application to FDA is an asset,
  • Understanding of HIPAA and importance of patient data privacy,
  • Outstanding interpersonal skills that include excellence in written communication, oral communication, negotiation, collaboration and problem-solving,
  • Great quality systems mindset and compliance to requirements,
  • Great documentation skills and attention to details,
  • Eager to learn and likes challenges.