Regulatory Systems Analyst Co-op

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

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At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.

Guided by a culture of continuous improvement that fosters resilience and self-motivation, our team is united by a shared commitment to excellence and a deep sense of pride in our work, each of us playing a vital role in creating meaningful change,

Here you’ll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.

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.
• 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.

Sonova is an equal opportunity employer.

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.