Senior Manager

Exponent•Philadelphia, PA

10d•Onsite

About The Position

Exponent is the only premium engineering and scientific consulting firm with the depth and breadth of expertise to solve our clients’ most profoundly unique, unprecedented, and urgent challenges. We are committed to engaging multidisciplinary teams of science, engineering, and regulatory experts to empower our clients with solutions that create a safer, healthier, more sustainable world. For over five decades, we've connected the lessons of past failures with tomorrow's solutions to advise clients as they innovate technologically complex products and processes, ensure the safety and health of their users, and address the challenges of sustainability. Join our team of experts with degrees from top programs at over 500 universities and extensive experience spanning a variety of industries. At Exponent, you’ll contribute to the diverse pool of ideas, talents, backgrounds, and experiences that drives our collaborative teamwork and breakthrough insights. Plus, we help you grow your career through mentoring, sponsorship, and a culture of learning. Thanks for your interest in joining our team! Our Opportunity We are currently seeking a Senior Manager in our Biomedical Engineering & Sciences Practice in Philadelphia, PL. In this role you will work as part of a team in a stimulating and challenging work environment with significant opportunities for professional growth. You will be responsible for Managing and executing complex projects in support of our clients Actively participating and providing leadership in our Biomedical Engineering & Sciences Practice Actively marketing the Practice’s technical and regulatory capabilities to clients and the scientific community Participating in complex technical projects in medical devices, pharma, biologics, and combination products in support of our clients as part of multidisciplinary teams Directing and performing regulatory strategy assessments, technical evaluations, analysis, and testing on the behalf of medical device or pharmaceutical/ biologic companies to support successful regulatory objectives Developing additional expertise, gaining additional industry exposure, and establishing a new and expanded client base through our unique technical and regulatory consulting services Expanding your own expertise through peer-reviewed publications, presentations, and developing the careers of support staff

Requirements

B.S. in Bioengineering, Biomedical Engineering, or a related field
At least 15 years of related professional experience, including regulatory and/or compliance experience with a variety of medical devices in the life sciences industry
Experience with medical device regulatory requirements (FDA and EU MDR)
Direct experience with total product lifecycle regulatory subject matter including US FDA class II (510(k)) and class III (PMA) medical device regulation and compliance
Familiarity with quality assurance and risk management activities to support medical devices/combination products related
Outstanding verbal and written communication skills in order to effectively communicate regulatory while possessing sufficient technical depth to collaborate with our clients and interact with regulatory bodies
Demonstrated capabilities and skillset to complement the skills of our existing consultants
A recognized expert in your field with a strong publication and/or presentation history
Strong leadership skills and the desire to be a strong subject matter expert and project contributor
The ability to attract projects and continuously expand your business volume to support full-time staff and the skills needed to manage, develop, and promote a group of highly motivated professionals
Presently legally authorized to work in the US, no immigration sponsorship or visa processing required

Nice To Haves

Established client relationships and a thriving consulting business is highly desirable; individuals with strong potential for business development through institutional support and resources will also be considered

Responsibilities

Managing and executing complex projects in support of our clients
Actively participating and providing leadership in our Biomedical Engineering & Sciences Practice
Actively marketing the Practice’s technical and regulatory capabilities to clients and the scientific community
Participating in complex technical projects in medical devices, pharma, biologics, and combination products in support of our clients as part of multidisciplinary teams
Directing and performing regulatory strategy assessments, technical evaluations, analysis, and testing on the behalf of medical device or pharmaceutical/ biologic companies to support successful regulatory objectives
Developing additional expertise, gaining additional industry exposure, and establishing a new and expanded client base through our unique technical and regulatory consulting services
Expanding your own expertise through peer-reviewed publications, presentations, and developing the careers of support staff