The Medical Regulatory Services team ensures patient safety while supporting timely market access for our clients' medical device products globally under a variety of certification schemes such as ISO 13485, INMETRO, UKCA, CE Marking and MDSAP. This is a home-based role with a 50-75% travel requirement. • Coordinates and/or performs Audits and Technical File Reviews. • Plan/schedule workloads to make best use of own time and maximize revenue-earning activity. • Initiates communication with clients to promote and explain the benefits of new and existing services. • Follows up on contacts from clients. • Communicates with clients to discuss technical issues, explain UL procedures and requirements, and convey project scope. • Acts to address client concerns and to resolve complex client issues. • Provides technical assistance to clients in reference to medical regulatory services. • Establishes appropriate project scope by reviewing files and manufacturer's information, examining documentation, and applying UL requirements. • Determines areas in which the product and QMS is not in compliance with UL and regulatory requirements or of any changes in project scope or certification and notifies client. • Coordinates administrative aspects of project management. • Communicates project status and results to clients through frequent contact and by preparing reports. • Integrates continuous improvement concepts and techniques into all aspects of the job. • Resolves complex engineering issues associated with Variation Notices by analyzing and reporting on the acceptability of the variations. • Develops UL requirements for testing products beyond the scope of existing standards, or those involving unique features requiring frequent use of independent judgment. • Develops special test methods and test equipment. • May represent UL on technical committees and/or industry-related functions such as seminars and trade shows. • Directs and reviews work of peer auditor staff. • Performs other duties as directed. • University Degree in Engineering, Biomedical Engineering, Biochemistry, Health Sciences, or Physics from an accredited program. • Minimum of 4 years experience in the medical device field including at least 2 years must be hands-on medical device design, manufacturing, testing or clinical evaluation experience. • Knowledge of business processes and application of quality management standards. • Good verbal and written communication skills and an eye for detail. • Working knowledge of conformity standards in use in areas of expertise. • Demonstrated ability to apply project-handling concepts in use in areas of expertise including application to complex, new, or unusual products. • Working knowledge of industry issues, needs, and problems. • Good public speaking and business development skill will be considered advantageous. • Ability to travel 50-75% domestically and internationally. • USA state issued driver's license without restrictions. • Valid USA passport without restrictions.