Regulatory Systems Analyst Co-op (Med Devices)

Sonova Group; Kitchener; On-site; CAD 25,000 - 30,000; Full time

Job summary

Sonova is seeking a Regulatory Systems Analyst Co-op to support regulatory activities for medical devices in global markets. You’ll assist with regulatory documentation, product registrations and cross-functional teamwork during product development and market clearance.

The role emphasizes learning in regulatory affairs, quality assurance, and understanding international regulatory landscapes in Canada, the US, and EU markets, with onsite work in Kitchener, Ontario and occasional remote days.

Qualifications

• Pursuing or recently completed bachelor’s degree in engineering, life sciences, or related field.
• Demonstrated interest in regulatory affairs, quality assurance or medical-device industry.
• General understanding of international regulatory landscape (Canada, USA, EU).

Responsibilities

• Support product-registration activities and help prepare regulatory documentation for product launches and market registrations.
• Maintain regulatory documents and assist with Declarations and Letters of Attestation.
• Assist with regulatory projects and act as a regulatory resource for cross-functional teams.
• Research evolving global medical-device regulations and regulatory requirements.
• Support licence updates and regulatory submissions for Health Canada, FDA and EU markets.

Skills

Regulatory affairs interest

Analytical skills

Communication skills

Independent and team player

Education

Bachelor’s degree in engineering or life sciences

Tools

Microsoft Office

Job description

Sonova is seeking a Regulatory Systems Analyst Co-op to support regulatory activities for medical devices in global markets. You’ll assist with regulatory documentation, product registrations and cross-functional teamwork during product development and market clearance.

The role emphasizes learning in regulatory affairs, quality assurance, and understanding international regulatory landscapes in Canada, the US, and EU markets, with onsite work in Kitchener, Ontario and occasional remote days.