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.)
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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.)
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