Regulatory Affairs Associate

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.)