Remote Senior Regulatory Affairs Specialist – Medical Devices

460w EPOCAL INC.; Canada; Remote; CAD 83,000 - 118,000; Full time

Job summary

Siemens Healthineers in Canada is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and maintain lifecycle documentation for medical devices and IVDs. You will collaborate with cross‑functional teams, provide guidance on design controls, and ensure audit-ready documentation while supporting internal training and regulatory projects.

The role requires a Bachelor’s degree in a scientific discipline, 4+ years of regulatory experience, GMP exposure, and strong attention

Qualifications

• Bachelor’s degree in scientific discipline.
• Minimum of 4 years of experience in IVDs or Medical devices.
• Skilled in Outlook, SharePoint, Adobe Acrobat, and Microsoft Office applications, including Excel and Azure DevOps.
• Experience of working in a GMP environment.
• Intercultural sensitivity.
• Strong attention to detail and excellent organizational skills.

Responsibilities

• Prepare, submit, and maintain regulatory submissions and lifecycle documentation.
• Serve as a Regulatory Affairs subject matter expert for design control and new product development teams.
• Prepare, submit, and maintain Technical Files under QMS.
• Collaborate with cross‑functional teams to develop and maintain quality guidelines and procedures.
• Independently or collaboratively lead and contribute to regulatory projects, ensuring timely execution.
• Provide training to internal stakeholders on country‑specific regulatory requirements.
• Review promotional and labeling materials for regulatory compliance.
• Ensure audit‑and inspection‑ready documentation and guidance on regulatory documentation practices.
• Participate in internal and external audits, including quality system audits and regulatory authority inspections.

Skills

GMP experience

Regulatory knowledge

Attention to detail

Cross-functional collaboration

Intercultural sensitivity

Communication skills

Education

Bachelor’s degree in scientific discipline

Tools

Outlook

SharePoint

Adobe Acrobat

Microsoft Office

Excel

Azure DevOps

Job description

Siemens Healthineers in Canada is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and maintain lifecycle documentation for medical devices and IVDs. You will collaborate with cross‑functional teams, provide guidance on design controls, and ensure audit-ready documentation while supporting internal training and regulatory projects.

The role requires a Bachelor’s degree in a scientific discipline, 4+ years of regulatory experience, GMP exposure, and strong attention