About the role#
Join the Quality and Regulatory Affairs team at Sonova Group as a Regulatory Systems Analyst Co-op. You will gain hands-on experience supporting the activities required to launch and maintain medical devices in global markets. This role involves preparing regulatory documentation, maintaining product-registration information, and working with cross-functional teams throughout the product development process.
What you'll do#
- Support product-registration activities and prepare technical documentation for product launches.
- Organize regulatory documents including Declarations of Equivalency, Declarations of Conformity, and Letters of Attestation.
- Research global medical-device regulations and requirements.
- Maintain Marketing Authorization lists to ensure registrations are complete for each market.
- Manage licence updates, regulatory submissions, and product databases for Health Canada, the U.S. FDA, and European Union markets.
- Assist project and Quality Assurance teams with Medical Device Risk Assessments, device labelling, and other product-development deliverables.
- Provide support for Regulatory Affairs activities, excluding implantable devices.
- Complete additional tasks assigned by the Manager or Director.
What you'll need#
- Currently pursuing or recently completed a bachelor’s degree in engineering, life sciences, a scientific discipline, or a related field.
- Demonstrated interest in regulatory affairs, quality assurance, or the medical-device industry.
- General understanding of international regulatory requirements in Canada, the United States, and the European Union.
- Strong analytical and problem-solving skills.
- Ability to work effectively both independently and as part of a team.
- Fluent English communication skills.
- Proficiency with Microsoft Office applications.
Location & details#
- This position is based in Kitchener, Ontario.
- The role is primarily on-site with the possibility of occasional remote workdays depending on business needs and manager approval.
- This is a full-time, paid co-op position.
About Sonova Group
Sonova Group manufactures medical equipment focused on hearing care. The company produces hearing aids, cochlear implants, and wireless communication systems. Its brands include Phonak, Unitron, and Advanced Bionics. Based in Stäfa, the organization operates in over 100 countries and employs more than 10,000 people.
How to get in at Sonova Group
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