Regulatory Affairs Specialist- Medical Devices We have a vision of a world where people globally have access to a wide range of safe and effective medical devices which is made possible by accurate and timely regulatory support for our clients. With ever changing guidelines throughout the world, it has become increasingly complicated to get a novel device approved for sale globally. For this to change, our clients need expert and trustable guidance with a quick turnaround. We are a company built on a foundation of challenging the status quo of how both employees and clients work together and grow efficiently by providing the highest level of customer satisfaction and success. Mittal Consulting is seeking a Regulatory Affairs Specialist to help build regulatory process tools and assist with our workload for upcoming projects. We're looking for someone to quickly embed themselves in the industry, showcase entrepreneurial candor and develop a strong regulatory work ethic. **If you are looking for a foot in the door for the Regulatory world- this is your opportunity! ** Responsibilities * Class II and III Medical Device Submissions * Prepare and submit PMA, 180 DS, RTR, 30 DN, 510(k) and De Novo submissions to the FDA * Compilation and submission of tech files/ design dossiers to notified bodies under new EU MDR regulations * Perform quality control (QC) review of regulatory submission documents, i.e., grammatical/spelling, formatting, flow and language and general clarity of text * Verify that documents meet all applicable regulatory submission standards * Maintain product submission planners, submission timelines, and submission logs * Work with clients to determine classification and regulatory pathways for US, EU, and other international markets. * Manage multiple, parallel projects to successful completion. Position Requirements & Experience * A minimum of a bachelor's and or undergraduate degree in biological, biomedical, chemical, engineering or equivalent sciences is required. * Background and work experience in Medical Devices (Not pharma) * Ability to engage with multiple time zones and work with North American and European clients. * Knowledge of FDA medical device regulations is required. Experience in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management is preferred. * Experience with DeNovo or PMAs is preferred. * Client centered focus and problem-solving skills are required. * Strong attention to detail with the ability to multitask and handle multiple responsibilities simultaneously * Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines * Ability to work independently and as part of a team * Minimum 1 year of related regulatory experience, including: * Writing and submitting at least one FDA regulatory submission in the past year. * Writing at least one new product introduction regulatory strategy. * Experience with submitting Pre-Submission meeting requests into the FDA and participating in those meetings. Work Environment and Details * Remote position (Headquarter is in Portland, Oregon) * Flexible Hours * 1099 contract position * Contractor to provide their own office supplies including laptop * Work specific software licenses will be provided (Email, Zoom, Microsoft, CRM etc as required) * Travel will be reimbursed as required https://www.linkedin.com/jobs/view/4082887389/<https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.linkedin.com%2Fjobs%2Fview%2F4082887389%2F&data=05%7C02%7CCbee-jobs%40engr.oregonstate.edu%7C457c4237f143411fc7d908dd0e6c8b42%7Cce6d05e13c5e4d6287a84c4a2713c113%7C0%7C0%7C638682581523261087%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=%2FWC4xKMyVmtT3hQaYOcgevFrnsmquiumi3U7hEsrfgo%3D&reserved=0> Josefine Fleetwood (She/Her), Employer Relations Manager Oregon State University | College of Engineering School of Chemical, Biological and Environmental Engineering School of Nuclear Science and Engineering Department of Biological and Ecological Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood@oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu>