Medical Device, Quality/Risk Management, Worldwide Regulatory Affairs
4 Year Degree
Begin your future with Ottobock. For more than 100 years, people have been the focus of everything we do. Our more than 7,000 employees in 50 countries work every day to help people maintain or regain their freedom of movement with innovative, technology-driven prosthetic and orthotic devices and industry-leading services. As a result of our continued growth and success, we have an opportunity on our Regulatory Team for a Regulatory Specialist position in our Salt Lake City, Utah location.
Provision, analysis and workable interpretation of applicable international legislations and regulations e.g. the Medical Device Regulation MDR, ordinances and standards with regard to the product portfolio.
Managing local cross-functional projects
Contribute to defining the RA strategy by providing regional RA trends
Process international product registrations in alignment with the RA strategy
Consulting employees in achieving and maintaining regulatory conformity as a prerequisite to worldwide market access.
Negotiations with competent authorities and other external institutions (i.e., for example in the context of product registrations).
Provides day-to-day regulatory support for new product design/ project teams. Support the implementation of regulatory requirements throughout company. Participate in research of regulatory issues and dissemination regulatory information to relevant departments or business units and senior management as required.
Assist with compliance oversight with applicable regulations. Maintain current knowledge of U.S. and international regulation, guidance and/or standards applicable to Otto Bock products. Interprets regulations and their changes to ensure that they are communicated to departmental stake holders and implemented into practice, as needed.
Participate in conducting Ottobock departmental audits to ensure compliance with established practices/policies/ or procedures as related to regulatory needs.
Coordinates and assists in on-going review of marketing materials, indications for use, and/or labeling and labels for compliance with applicable regulatory requirements.
Maintain departmental files/databases, including registrations, technical files, device listings, certificates and licenses; Establish and maintain system for tracking changes in documents submitted to agencies or partners
Assist in preparation and clearance of domestic product submissions, including registration requirements and other applicable regulatory requirements.
Knowledge and experience
BA of Regulatory Sciences preferred
Regulatory experience with healthcare or medical device company including premarket activities, with MDR experience preferred
Effective communication skills; written and verbal
Demonstrated organizational development skills
Demonstrates good judgment and decision-making skills
Collaborates and builds relationships well
Ability to effectively balance multiple projects
Ability to identify problems and review information to evaluate options and recommend solutions
Internal Number: 0001
All over the world, the name Ottobock is a synonym for high-quality and technologically outstanding medical technology products and services. The goal of helping to restore mobility to people with disabilities, and protect what mobility they have, stands behind each and every one of the company's products. Our conviction that quality of life is closely connected to a maximum of individual freedom and independence is a key concept that has been a major influence throughout the company's nearly 100-year history and guides the development of new products in a focused manner.