Regulatory Affairs Engineer

Innovative Health•Scottsdale, AZ

11d

About The Position

The Regulatory Affairs Engineer prepares and submits FDA 510(k) documentation to obtain clearance for commercial product distribution and supports regulatory submissions and maintenance for international regulatory bodies. The role reviews complaints and adverse events for MDR submissions and evaluates test protocols, reports, and other submission materials for accuracy, legibility, and completeness. The position participates in product and process development teams, reviewing plans, reports, risk management activities, risk assessments, and design reviews. It provides regulatory assessments for manufacturing activities, line extensions, design changes, and validation; participates in internal and external audits and supports responses to findings; and reviews and approves change orders, CAPA/nonconformance documentation, and related project materials. Additional duties include supporting compliant labeling and IFU development, reviewing promotional materials, implementing and maintaining UDI activities, assisting with FMEA risk assessments, keeping current with regulations and standards, developing and implementing company policies and procedures, and maintaining the regulatory documentation repository.

Requirements

Bachelor's degree in a technical field such as bioengineering, electrical engineering, or mechanical engineering.
Minimum of three years of medical device experience.
Experience and knowledge of FDA 21 CFR Part 820 and 510(k) submission requirements.
Working knowledge of QMS systems and functionality.
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, including 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 and software such as Word, PowerPoint, Excel, Project, and Minitab.
Self-starter and highly motivated.

Nice To Haves

Experience and knowledge of Canadian Medical Device Regulations, MDD, MDSAP, and ISO standards.
Previous 510(k) submissions.

Responsibilities

Prepare and manage FDA 510(k) submissions to obtain clearance for commercial product distribution.
Provide documentation and support for submissions and maintenance of regulatory documents for international regulatory bodies.
Review complaints and adverse events for MDR submission.
Review and approve test protocols, reports, and other materials for regulatory submissions, checking for errors, legibility, and missing information.
Participate in project development teams and review plans, reports, risk management, risk assessments, and design reviews for product and process projects.
Provide regulatory assessments for manufacturing, line extensions, design changes, and validation activities.
Participate in internal and external audits and prepare responses supporting audit findings or related actions.
Conduct regulatory review and approval of change orders, CAPA/nonconformance, and related project documentation.
Assist with label and IFU development and review materials for compliance before release.
Review promotional material for compliance with applicable regulations.
Implement and maintain unique device identifier (UDI) activities for implementation and compliance.
Assist with FMEA risk assessments.
Maintain and disseminate current knowledge of regulations, standards, and guidance documents, and seek information to resolve questions related to assigned projects.
Develop and implement company policies and procedures.
Assist in archiving regulatory documentation and maintaining the related repository.