Regulatory Systems Analyst Co-op

Regulatory Systems Analyst Co-op

Kitchener, Ontario | Primarily Onsite with Possible Remote Days

Join Sonova’s Quality and Regulatory Affairs team as a Regulatory Systems Analyst Co-op and gain hands-on experience supporting the regulatory activities required to launch and maintain medical devices in global markets.

In this role, you will help prepare regulatory documentation, maintain product-registration information and support cross-functional teams throughout the product development and market-registration process.

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 the 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.

More About You

• 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 your 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.

Work Arrangement

This position is based in Kitchener, Ontario and will work primarily onsite, with the possibility of occasional remote workdays depending on business needs, assigned responsibilities and manager approval.