Regulatory Affairs Engineer

Summary

Job Description Job Description

The Regulatory Affairs Engineer 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;
• 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;
• Assist with label and IFU development and review for compliance before release;
• Review promotional material to ensure compliance with applicable regulations;
• Implement and maintain unique identifier (UDI) activities for implementation/compliance ;
• Assists with FMEA 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 repository.

Qualifications:

• Minimum of Bachelor's degree in technical field (i.e. Bioengineering, Electrical Engineering, Mechanical Engineering or other technical field);
• Experience and 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 three years medical device experience;
• Working knowledge of QMS systems and functionality;
• Previous 510(k) submissions; preferred
• 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.

Job Description

Job Description Job Description

The Regulatory Affairs Engineer 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;
• 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;
• Assist with label and IFU development and review for compliance before release;
• Review promotional material to ensure compliance with applicable regulations;
• Implement and maintain unique identifier (UDI) activities for implementation/compliance ;
• Assists with FMEA 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 repository.

Qualifications:

• Minimum of Bachelor's degree in technical field (i.e. Bioengineering, Electrical Engineering, Mechanical Engineering or other technical field);
• Experience and 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 three years medical device experience;
• Working knowledge of QMS systems and functionality;
• Previous 510(k) submissions; preferred
• 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.