The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies.

• Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially distribute product;
• Provides documentation and support for the submission/maintenance of regulatory documents for international regulatory bodies;
• Acts as the liaison between Innovative Health, the FDA and other international regulatory bodies;
• 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;
• 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;
• Participates in internal/external audits and prepares responses to support audit findings or other respective actions related to such audits;
• Conduct regulatory review and approval of change orders, CAPA/nonconformance, and related project documentation;
• Review labeling and promotional material to ensure compliance with applicable regulations;
• Implement and maintain unique identifier (UDI) activities for implementation /compliance;
• Review clinical documents to ensure that data collection and submission meets global and regional accepted regulatory standards;
• Assists with DFMEA and PFMEA risk assessments;
• Maintain and disseminate current knowledge base of existing regulations, standards, or guidance documents and proactively seek and find information to help resolve questions related to assigned projects;
• Develops and implements company policies and procedures;
• Assists in archiving regulatory documentation and maintaining related databases.

Qualifications:

• Minimum of Bachelor’s degree in technical field (i.e. Bioengineering, Electrical Engineering, Mechanical Engineering or other technical field);
• Expert level knowledge of FDA 21 CFR Part 820 and 510K submission requirements;
• Experience and knowledge of Canadian Medical Device Regulations, MDD, MDSAP and ISO standards preferred;
• Minimum of five years medical device regulatory experience;
• Previous 510(k) submissions;
• Ability to work in a fast paced, collaborative team environment;
• Ability to handle multiple projects and coordinate cross functional teams;
• Ability to communicate effectively with management, direct reports and external vendors;
• Ability to write technical documents (procedures, test methods, protocols and reports);
• Ability to recommend technical solutions;
• Ability to specify regulatory requirements for products;
• Ability to work with little supervision;
• Ability to use personal computers including software such as: Word, PowerPoint, Excel, Project and Minitab;
• Self-starter and highly motivated;
• Sterilization experience is a plus.

• Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially distribute product;
• Provides documentation and support for the submission/maintenance of regulatory documents for international regulatory bodies;
• Acts as the liaison between Innovative Health, the FDA and other international regulatory bodies;
• 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;
• 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;
• Participates in internal/external audits and prepares responses to support audit findings or other respective actions related to such audits;
• Conduct regulatory review and approval of change orders, CAPA/nonconformance, and related project documentation;
• Review labeling and promotional material to ensure compliance with applicable regulations;
• Implement and maintain unique identifier (UDI) activities for implementation /compliance;
• Review clinical documents to ensure that data collection and submission meets global and regional accepted regulatory standards;
• Assists with DFMEA and PFMEA risk assessments;
• Maintain and disseminate current knowledge base of existing regulations, standards, or guidance documents and proactively seek and find information to help resolve questions related to assigned projects;
• Develops and implements company policies and procedures;
• Assists in archiving regulatory documentation and maintaining related databases