Medical Device Regulatory Specialist

Company: Corvita Biomedical Inc.

Location: Greater Toronto Area, Ontario, Canada - Hybrid

Employment: Full-time, permanent

Experience: Entry level; 0 to 2 years, including co-op or internship experience

Reports to: Senior Regulatory Manager

Start date: As soon as mutually agreed

About Corvita BiomedicalCorvita Biomedical Inc. is a mission-driven medical device startup transforming neonatal healthcare globally. We are developing the ARK Incubator, designed to democratize access to intensive care for premature and critically ill newborns. Our technology addresses the global crisis where millions of infants die annually due to lack of access to proper neonatal intensive care, particularly in underserved communities, rural areas, and humanitarian settings.

As a member of our team, you'll have the unique opportunity to directly impact infant mortality rates and health outcomes on a global scale.

Role SummaryThe Medical Device Regulatory Specialist will support Corvita's Health Canada-first regulatory program under the direct supervision of the Senior Regulatory Manager.

This role is for someone who is highly organized, writes clearly, and enjoys turning complex technical work into accurate, traceable records. You will help assemble submissions, maintain controlled documentation, coordinate regulatory actions, and confirm that evidence from engineering, clinical, quality, and manufacturing activities is complete and easy to retrieve.

This role does not independently approve regulatory strategies, product claims, submissions, design changes, or compliance decisions. Final decisions and external regulatory communications remain with the Senior Regulatory Manager and designated company approvers.

Key ResponsibilitiesRegulatory research and submission support

- Support research into Canadian medical-device classification, licensing requirements, recognized standards, and submission pathways.
- Maintain submission plans, content indexes, evidence matrices, gap lists, and regulatory timelines.
- Collect, organize, and perform completeness checks on technical, clinical, risk-management, manufacturing, and verification records.
- Draft, format, and cross-reference submission sections under the Senior Regulatory Manager's direction.
- Maintain records of regulator questions, responses, commitments, and follow-up actions.

Quality-system and design-control documentation





- Help maintain design and development plans, requirements, review records, traceability matrices, design-transfer records, and supporting evidence.
- Support links among product requirements, identified risks, risk controls, design outputs, and verification evidence.
- Assist with controlled procedures, work instructions, forms, templates, and training records.
- Check documents for required authors, reviewers, approvals, dates, references, and revision history.
- Support deviation, CAPA, supplier-document, and audit-action follow-up as assigned.

Document control and standards management

- Administer document numbering, version control, approval routing, distribution, archival, and obsolescence processes.
- Maintain an accurate standards and regulatory-requirements register.
- Track current or revised requirements and prepare preliminary applicability or gap summaries for senior review.
- Maintain organized audit trails and ensure that approved records can be retrieved quickly.
- Help keep the regulatory and quality portions of Corvita's data room current.

Change labelling and product-information support

- Gather information for preliminary regulatory-impact assessments of design, software, supplier, manufacturing, and labelling changes.
- Route change assessments to engineering, quality, and the Senior Regulatory Manager for final decisions.
- Review draft labels, packaging, instructions for use, and product claims for consistency with approved intended use, risk controls, and available evidence.

Audit readiness and coordination

- Prepare evidence indexes and document packages for internal reviews, supplier audits, and regulatory inspections.
- Support mock audits and record observations, decisions, and resulting actions.
- Maintain regulatory action logs, meeting minutes, decision records, owners, and due dates.
- Follow up respectfully with technical owners to close documentation and evidence gaps.
- Prepare concise status summaries and escalate delays or compliance risks promptly.





Required Qualifications

- Bachelor's degree or diploma in biomedical engineering; regulatory affairs; or public health.
- Zero to two years of relevant experience. Internships, co-op placements, capstone projects, and regulated-industry placements are welcome.
- Strong written English and the ability to organize technical information clearly and accurately.
- Excellent attention to detail, record-keeping, and follow-through.
- Basic understanding of the medical-device development lifecycle, risk management, or quality systems.
- Ability to work across engineering disciplines while asking questions and escalating uncertainty appropriately.
- Comfort with document-management tools, spreadsheets, trackers, and structured templates.

Preferred Qualifications

- Coursework, training, or project exposure related to Health Canada medical-device requirements, ISO 13485, ISO 14971, or design controls.
- Familiarity with one or more of IEC 60601, IEC 62304, IEC 62366-1, medical-device cybersecurity, or biological-evaluation principles.
- Experience with an electronic QMS, requirements-management system, or controlled document repository.
- Exposure to verification testing, risk files, usability engineering, labelling, or submission preparation.
- Experience in a medical-device, healthcare, laboratory, engineering, or other regulated environment.
- French-language ability is an asset but is not required.

What We Offer

- Direct mentorship and day-to-day supervision from a Senior Regulatory Manager.
- Meaningful responsibility on a multidisciplinary Canadian medical-device program.
- Exposure to design controls, verification, manufacturing transfer, audit preparation, and regulatory submissions.
- Close collaboration with mechanical, electrical, embedded, software, biomedical, data, clinical, quality, and operations teams.
- An opportunity to build practical regulatory and quality judgment early in your career.

How to ApplyPlease email the following to [email protected]:

- Resume or CV.
- A brief cover letter explaining your interest and relevant experience.
- In your cover letter, describe one project that required careful documentation.

Please do not include confidential or proprietary information from a current or former employer. Applications will be reviewed on a rolling basis until the position is filled.

📌 Medical Device Regulatory Specialist (Toronto)
🏢 Corvita Biomedical
📍 Toronto