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.
