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Exponent Biomedical Regulatory Associate/Senior Associate in Philadelphia, Pennsylvania

Reference #: 4729Exponent is a leading engineering and scientific consulting firm that brings together more than 90 different disciplines to solve the most pressing and complicated challenges facing stakeholders today. Our vision is to engage the brightest scientists and engineers to empower clients with solutions for a safe, healthy, sustainable and technologically complex world. We leverage over 50 years of experience in analyzing accidents and failures to advise clients as they innovate their technologically complex products and processes, ensure the safety and health of their users, and address the challenges of sustainability.We offer opportunities for you to expand your engineering or scientific knowledge amidst experts from top programs at over 500 universities. At Exponent, you will apply your experience, technical skills, and prior academic research to a fulfilling career in consulting. You will have the opportunity to develop continuously through formal and informal development programs, coaching and mentoring, and involvement in a wide array of projects. We are excited about your interest in joining our growing team!Key statistics:1100+ Team members900+ Consultants550+ Ph.D.'s30+ Offices globallyWe are currently seeking a Biomedical Associate/Senior Associatewith experience in regulatory affairs of medical devices/combination products (MD/CP) for ourPractice in Philadelphia, PA. In this role you will work as part of a team to solve difficult problems for our clients in the regulatory space.You will be responsible for:Managing and executing projects related to pre- and post-market regulatory activities for various MD/CP technologies where topics relate to the design, testing/evaluation, and applications to support commercialization in global markets.Performing strategic and technical evaluations, analysis, testing, and execution of regulatory documentation on the behalf of multinational companies to support successful regulatory objectives.Designing and implementing custom experimental methods to address unique aspects of complex productsAssessing biomaterials and medical implants using experimental and computational toolsPublishing at conferences and in peer-reviewed literatureAssisting in marketing the Biomedical Engineering Practice's capabilities to clients and the scientific communityDeveloping additional expertise and gaining additional industry exposure through learning and leveraging Exponent's unique technical consulting servicesYou will have the following skills and qualifications:M.S. or Ph.D. in ascience or engineering related field3-5 years in a regulated healthcare industry with focused experience in product research/development and/or regulatory affairs activities.Direct experience with total product lifecycle regulatory subject matter including US FDA class II (510(k)) and class III (PMA) medical device regulationsFamiliarity with quality assurance and risk management activities to support medical devices/combination products including international standardsAbility to work on diverse technical teams made up of engineers, scientists, clinicians, statisticians, etc.Excellent verbal and written communication skillsStrong leadership skills and the desire to be a strong technical and project contributorTo learn more about life at Exponent, check out our Graduate Students page at !We valueand encourage diversity and inclusivity across all facets of our firm. Having a team built of people with different backgrounds, skills and perspectives allows us to provide better value to our clients and enjoy an enriched work environment.Our firm is committed to offering a variety of programs and resources to support health and well-being. We believe that providing competitive benefits as well as compensation and recognition programs empowers our staff to do work that makes a difference.If you need assistance or accommodation due to a disability, you may call us at +1 (650) 688-6968 or email .Exponent is a proud equal