IoT Systems Engineer developing C++ and Linux - based connected - device systems for intelligent infrastructure and transportation. Supporting hardware preparation, customer deployments, field testing, and troubleshooting.
About the role
- Regulatory Systems Analyst Co-op supporting Sonova’s medical-device launches and global registrations. Maintaining regulatory documentation, databases and compliance records for Health Canada, FDA and EU markets.
Responsibilities
- Support product-registration activities and help prepare technical documentation for product launches and market registrations
- Prepare and organize regulatory documents, including Declarations of Equivalency, Declarations of Conformity and Letters of Attestation
- Assist with regulatory projects and provide support as a regulatory subject-matter resource
- Research evolving global medical-device regulations and regulatory requirements
- Support maintenance of Marketing Authorization lists to ensure required medical and technical registrations are completed for each market
- Maintain accurate licence updates, regulatory submissions and product databases, particularly for Health Canada, the U.S. FDA and European Union markets
- Support project and Quality Assurance teams with Medical Device Risk Assessments, device labelling and other product-development deliverables
- Assist with Regulatory Affairs activities for Sonova products, excluding implantable devices
- Complete additional responsibilities and projects assigned by the Manager or Director
Requirements
- 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 the international regulatory landscape, including requirements in Canada, the United States and European Union
- Strong analytical and problem-solving skills
- Driven, enthusiastic and interested in developing regulatory knowledge
- Excellent interpersonal and communication skills
- Able to work effectively both independently and as part of a team
- Fluent English communication skills
- Proficiency with Microsoft Office applications
Benefits
- Equal opportunity employment
- Opportunity to gain hands-on experience in regulatory activities for medical devices
- Possibility of occasional remote workdays depending on business needs, assigned responsibilities and manager approval
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