Regulatory Affairs Associate in Toronto at Apex Life Sciences

Date Posted: 4/4/2018

Job Snapshot

Job Description

Regulatory Affairs Associate - Medical Device

Apex Life Sciences is recruiting for a Regulatory Affairs Associate for a small medical device company in Toronto, ON. Our client is a medical device manufacturer of diagnostic devices and they are searching for a Regulatory Affairs Associate for a 1-year maternity leave contract. This role offers the chance to join a growing company and provide strategic input to the development process and the maintenance and care of existing product lines.

Responsibilities and Duties

  • Interpret, apply and oversee national and international regulations.
  • Manage project timelines.
  • Coordinate and develop regulatory submissions.
  • Develop regulatory strategies and development plans.
  • Provide regulatory support to the development team to reduce time to market.
  • Identify and manage product and process risks.
  • Review of product failures and management of advisory notice processes and recall.
  • Internal and External regulatory inspections.
  • Stay up to date with regulatory changes and communicate them to management and internal stakeholders.
  • Manage data in the regulatory information management system.

Qualifications and Skills

  • MSc or BSc in a scientific or engineering discipline.
  • 2+ years of medical device regulatory experience (additional certificate preferred but not required).
  • Understanding of medical device quality systems and regulations (ISO 13485, IVDD, MDR and QSR).
  • Project management experience.
  • Excellent communication and interpersonal skills.
  • Good attitude and not afraid of change.
  • Organized and highly computer literate.