Regulatory Systems Analyst Co-op

Sonova
Kitchener
Workplace: HybridInternshipFunction: Quality & Regulatory (Non-Software)Education: bachelorsSkills: ["Analytical skills","Problem-solving","Communication","Interpersonal skills","Teamwork"]

Support Sonova’s Quality and Regulatory Affairs team by helping manage regulatory documentation and product-registration information for medical devices across global markets. Prepare technical materials for product launches and market registrations, maintain marketing authorization and license updates for Health Canada, the U.S. FDA, and the EU, and assist cross-functional teams with risk assessments, labeling, and regulatory projects.

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FursaFursa
Sonova
Sonova
2 days ago

Regulatory Systems Analyst Co-op

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Last checked: 11 hours agoStatus: Live

Job Summary

Support Sonova’s Quality and Regulatory Affairs team by helping manage regulatory documentation and product-registration information for medical devices across global markets. Prepare technical materials for product launches and market registrations, maintain marketing authorization and license updates for Health Canada, the U.S. FDA, and the EU, and assist cross-functional teams with risk assessments, labeling, and regulatory projects.
Location: Kitchener
Workplace: Hybrid
Employment Type: Internship
Job Function: Quality & Regulatory (Non-Software)
Seniority: Intern level

Key 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.
  • •Research evolving global medical-device regulations and regulatory requirements.
  • •Maintain Marketing Authorization lists and accurate licence updates, regulatory submissions, and product databases for Health Canada, the U.S. FDA, and the European Union.
  • •Support project and Quality Assurance teams with Medical Device Risk Assessments, device labelling, and other product-development deliverables.

Key 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.
  • •Fluent English communication skills and proficiency with Microsoft Office.
Education:Bachelor's
Skills:Analytical skillsProblem-solvingCommunicationInterpersonal skillsTeamwork
Languages:English
Tech Stack:Microsoft Office

Company Brief

Sonova
Designs, manufactures, and distributes hearing care solutions including hearing aids, cochlear implant accessories, and wireless communication devices, serving audiologists and consumers worldwide through clinics, retail networks, and distribution partners.
Industry: Medical Devices
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Stäfa, Switzerland
Founded: 1947
Website