Remote Senior Regulatory Affairs Specialist (Devices)

Siemens Healthineers; Ottawa; Remote; CAD 83,000 - 118,000; Full time

Benefits offered by this job

Flexible benefits

Pension plan

RRSP matching

Paid time off

Job summary

Siemens Healthineers Canada is seeking a Senior Regulatory Affairs Specialist to lead submissions for FDA 510(k), IVDR, and other regulatory activities. This remote role supports cross‑functional teams and quality systems, ensuring compliant lifecycle documentation.

The ideal candidate has 4+ years in IVDs or medical devices, GMP experience, and strong communication skills. You will train stakeholders, review labeling, and prepare technical files while staying audit‑ready in a dynamic healthtech

Qualifications

• Bachelor’s degree in scientific discipline.
• Minimum 4 years of experience in IVDs or medical devices.
• Knowledge of US/EU regulations for medical devices and IVDs.
• Experience in GMP environment and regulatory submissions.
• Strong written and verbal communication skills.

Responsibilities

• Prepare, submit, and maintain regulatory submissions and lifecycle documentation (FDA 510(k), IVDR, notes to file).
• Serve as a Regulatory Affairs SME, guiding design control and new product development teams.
• Prepare, submit, and maintain Technical Files compliant with regulatory requirements and QMS.
• Collaborate with cross‑functional teams to develop quality guidelines and work instructions for regulatory compliance.
• Lead or contribute to regulatory projects, ensuring timely execution and alignment with strategy.
• Provide training to internal stakeholders on country‑specific regulatory requirements.
• Review promotional and labeling materials for regulatory compliance.
• Ensure audit‑ and inspection‑ready documentation; support internal/external audits and inspections.

Skills

Regulatory knowledge

GMP experience

Stakeholder communication

Cross-functional collaboration

Attention to detail

Multitasking

Intercultural sensitivity

Presentation skills

Education

Bachelor’s degree in scientific discipline

Tools

Outlook

SharePoint

Adobe Acrobat

Microsoft Office

Excel

Azure DevOps

Job description

Siemens Healthineers Canada is seeking a Senior Regulatory Affairs Specialist to lead submissions for FDA 510(k), IVDR, and other regulatory activities. This remote role supports cross‑functional teams and quality systems, ensuring compliant lifecycle documentation.

The ideal candidate has 4+ years in IVDs or medical devices, GMP experience, and strong communication skills. You will train stakeholders, review labeling, and prepare technical files while staying audit‑ready in a dynamic healthtech