Regulatory Affairs Specialist

About Percucision

Percucision is a Montréal-based medical technology company developing innovative medical devices designed to improve patient monitoring and clinical decision-making.

We are a growing, multidisciplinary team working across engineering, product development, quality, clinical, and regulatory affairs to bring new medical technologies from concept through regulatory approval and commercialization.

We are looking for a Junior Regulatory Affairs Associate to join our team and support the regulatory activities required to bring our products to market in Canada, the United States, and other international markets.

A key part of this role will be supporting the company through the regulatory activities required to achieve FDA clearance for our medical device, while also contributing to Health Canada and future international regulatory submissions.

What You’ll Do

As a Junior Regulatory Affairs Associate, you will support the development and execution of regulatory strategies for our medical devices.

• Lead the preparation, compilation, and submission of regulatory applications, including FDA 510(k) submissions and Health Canada Medical Device License (MDL) applications and MDSAP/MDEL.
• Lead the company in achieving FDA-cleared status, including supporting submission planning, documentation preparation, regulatory gap assessments, agency responses, and follow-up activities.
• Work with internal teams and external regulatory consultants to help define and execute the regulatory pathway toward U.S. market clearance.
• Assist in developing regulatory strategies for new products and product changes.
• Maintain regulatory documentation, submission records, registrations, and regulatory correspondence.
• Research and monitor changes to applicable Canadian, U.S., and international medical-device regulations, standards, and guidance documents.
• Support regulatory assessments of design, material, manufacturing, software, labeling, and other product changes.
• Lead with responses to questions and requests for information from regulatory authorities.
• Review product labeling, instructions for use, technical documentation, and promotional materials for regulatory compliance.
• Work closely with engineering, quality, clinical, and product-development teams to ensure regulatory requirements are incorporated throughout the product-development process.
• Support the preparation and maintenance of technical documentation, including design-control, verification and validation, and risk-management documentation.
• Assist with regulatory compliance activities, audits, registrations, and Quality Management System documentation and implementation.
• Maintain regulatory timelines, submission trackers, and project documentation.
• Support international regulatory research and market-entry assessments as the company expands.

What We’re Looking For

We are looking for someone who is organized, analytical, proactive, and interested in taking an active role in bringing a medical device through the regulatory clearance process.

Required qualifications:

• Bachelor’s degree in engineering, biomedical engineering, life sciences, health sciences, regulatory affairs, or another relevant scientific discipline.
• 2+ years of relevant experience in regulatory affairs within the medical-device industry.
• Experience supporting regulatory submissions or regulatory activities for medical devices.
• Strong understanding of regulatory documentation and the medical-device product development process.
• Strong written and verbal communication skills.
• Strong attention to detail and ability to work with complex technical documentation.
• Ability to understand and communicate scientific and engineering concepts.
• Strong organizational and project management skills with the ability to manage multiple priorities.
• Ability to work collaboratively with engineering, quality, clinical, and business teams.
• Professional proficiency in English and French.

Nice to Have

• Direct experience supporting or preparing an FDA 510(k) submission.
• Experience interacting with or responding to questions from the U.S. FDA or Health Canada.
• Familiarity with FDA medical-device regulations and guidance documents.
• Familiarity with Health Canada Medical Device Regulations.
• Experience with regulatory strategy, predicate-device analysis, or substantial-equivalence assessments.
• Knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 60601, or other applicable medical-device standards.
• Experience preparing or reviewing technical documentation, design-control documentation, verification and validation records, or risk-management files.
• Knowledge of IMDRF documentation or Health Canada REP submissions.
• Master’s degree or graduate-level education in regulatory affairs, biomedical engineering, engineering, life sciences, or a related field.
• Experience working in a startup or fast-paced medical-device product-development environment.

Why Join Percucision?

You will have the opportunity to work closely with a small, multidisciplinary team where your work will have a direct impact on the development, regulatory clearance, and commercialization of new medical technology.

This role provides the opportunity to participate directly in the company’s path toward FDA clearance, working across regulatory strategy, 510(k) preparation, design controls, risk management, quality systems, verification and validation, and product development.

Unlike highly specialized roles at larger organizations, you will gain broad exposure to the complete medical-device regulatory process and have the opportunity to take on increasing responsibility as the company grows.

If you are interested in medical technology, enjoy working at the intersection of engineering, healthcare, and regulation, and want to play an active role in bringing a new medical device through FDA clearance and into the market, we would like to hear from you.