Regulatory Affairs Professional
Apply NowCompany: Tech Tammina
Location: Oakville, ON L6H 0A4
Description:
Position: Regulatory Affairs Professional
Industry: Manufacturing
Location: Oakville, ON
Requirements:
Industry: Manufacturing
Location: Oakville, ON
Requirements:
- Strong working knowledge and experience of Health Canada's Food & Drugs Act, Medical Devices Regulations & associated guidance documents.
- Experience in Class III-IV medical device submissions to Health Canada (IVD experience - preferred)
- Analyze the medical device license application requirements, & prepare product-related regulatory applications to Health Canada.
- Build relationships, & liaise with Siemens internal organizations (e.g. Business Lines) to plan & prepare product related regulatory activities.
- Assist with assessing product changes (PCNs) for regulatory impact.
- Assist with reviewing/approving promotional material against relevant Medical Device Regulations (MDRs).
- Ensure creation of adequate documentation for audits/inspections, including updating of electronic department files, & initiate & escalate necessary activities if deviations are identified.