The Principal Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for the submission of pre-market applications, periodic updates and registrations to regulatory agencies. The position collaborates closely with the Regulatory Affairs Leadership to plan, implement, and coordinate regulatory activities. This strategic, high-impact role leads regulatory strategy, submissions, and compliance activities for high-risk medical devices throughout the product lifecycle.

Essential Duties and Responsibilities:

· Prepare and submit pre-market and post-market regulatory filings for Class II and Class III medical devices, including Q-submissions, pre-submissions, and interactive review cycles, to obtain FDA clearance or approval and Health Canada licenses for commercial product distribution.

· Review and approve test protocols, reports, and supporting documentation from cross-functional teams to ensure regulatory submissions are complete, accurate, legible, and submission-ready.

· Prepare routine regulatory correspondence and ensure timely submission to government agencies in support of marketed products.

· Participate in product and process development teams by reviewing project plans, reports, risk management files, risk assessments, and design review documentation.

· Prepare regulatory assessments for manufacturing changes, line extensions, design changes, validation activities, and Class III device lifecycle activities to determine whether additional regulatory submissions or agency notifications are required, including 510(k) submissions, U.S. Letters to File, PMA (i.e PMR) supplements, annual reports, or Canadian license amendments.

· Maintain current knowledge of applicable regulations, standards, and guidance documents, and proactively research information needed to resolve regulatory questions for assigned projects.

· Develop and maintain regulatory procedures and policies to support compliance with applicable regulatory requirements.

· Review complaints and adverse events to determine Medical Device Reporting (MDR) submission requirements.

· Review labeling and promotional materials to ensure compliance with applicable regulations.

· Participate in internal and external audits and prepare responses that support audit findings or related corrective actions.

· Conduct regulatory review and approval of change orders, CAPA/nonconformance records, and related project documentation.

· Coordinate product corrections and removals, including recalls, market withdrawals, and stock retrievals, in accordance with procedures and applicable regulations.

· Design, develop, and deliver regulatory training for employees.

· Maintain Unique Device Identifier (UDI) activities to support implementation and ongoing compliance.

· Maintain regulatory registrations and product listings.

· Assist in negotiations and communications with the FDA and other regulatory agencies.

· Perform other reasonable duties, as assigned.

Supervisory Responsibilities:

None

Education, Qualifications and Skills:

· Bachelor's degree in life sciences or a related field, with a minimum of 10 years of progressive regulatory affairs experience in the medical device industry; or an equivalent combination of education and experience.

· Expert-level knowledge of FDA 21 CFR Part 820 and applicable 510(k) submission requirements.

· Demonstrated experience authoring 510(k) submissions for Class II devices and pre-market approval applications for Class III devices.

· Experience with Canadian Medical Device Regulations, MDSAP, and applicable ISO standards.

· Strong technical background and expertise in Class III medical devices, with the ability to ensure regulatory requirements are met through effective cross-functional collaboration.

· Ability to work effectively in a fast-paced, collaborative team environment.

· Ability to manage multiple projects and coordinate priorities across cross-functional teams.

· Ability to address difficult situations and issues in a timely, professional, and effective manner.

· Ability to apply principles of engineering, science, and medical device use to develop sound technical and regulatory solutions.

· Ability to define and communicate regulatory requirements for a range of products.

· Excellent attention to detail with a results-oriented approach.

· Proficiency in Microsoft Word and other commonly used applications, including Excel, PowerPoint, Adobe Acrobat, and Visio.

· Ability to work independently under general guidelines and supervision from Regulatory Affairs Leadership.

· Self-starter with a high level of motivation and accountability.

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