Regulatory Affairs Associate- Onsite Only

The Regulatory Affairs Associate role is responsible for assisting with preparing and submitting the appropriate documentation for pre-market submissions (i.e. FDA 510(k) submissions, Health Canada Device License Applications). This role also supports post-market regulatory compliance activities. Role and Responsibities: Assisting with responses to deficiency letters and other requests for documentation for submissions. Reviews complaints/adverse events for submission of MDRs;Review and approve test protocols/reports and other documentation/information for regulatory submissions from various functional areas and check for errors, legibility, and missing information;Assist with the development of labeling and ensure compliance with applicable regulations;Participate in project development teams and review plans, reports, risk management, risk assessments and design reviews associated with product and process projects;Provide regulatory assessments for manufacturing, line extensions, design changes, and validation activities;Conduct regulatory review and approval of change orders and related project documentation;Implement and maintain unique identifier (UDI) activities for compliance;Assists with PFMEA risk assessments;Assists in archiving regulatory documentation and maintaining related databases; Participate in internal and external audits;Assist with other Regulatory projects and activities as required. Education and Qualifications: Minimum of Bachelor's degree (preferably in (i.e. Engineering, Biological Sciences, or other technical field) or equivalent education, training and experience;Minimum of one (1) year medical device regulatory and/or quality experience;Basic knowledge of FDA 21 CFR Part 820, ISO13485, and 510(k) submission requirements preferred;Basic knowledge of Canadian Medical Device Regulations, MDD, MDSAP and ISO standards preferred;High degree of initiative, be able to balance a variety of tasks, and with strong organizational abilities; Strong commitment to quality, accuracy and detail; Excellent oral & written communications skills;Excellent interpersonal skills are required, due to the numerous internal customers with varying and unique requirements/ priorities. Must understand the nature of the work and the impact it has on the organization.Ability to work in a fast paced/entrepreneurial team environment; Proficient in computer applications (i.e. Microsoft Office, Word, PowerPoint, Excel, etc.)

Created: 2026-03-04