Vice President, Technical - Medical Devices (Remote)
Posted 2025-04-06Incredible opportunity to bring your Health Authority experience and Medical Device expertise to Parexel as a Vice President, Technical!
The VP-Technical (Medical Devices) serves as a luminary in this product area for the Regulatory Consulting business. The VP-Technical (Medical Devices) possesses superior knowledge and specialized training in this area, as demonstrated by their prior roles a senior-level member at a Health Authority or in the pharmaceutical industry (e.g., Medical Device Team Leader, Master/Senior Reviewer, Assoc. Director, Section Head etc.).
A Technical Vice President must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations. The VP-Technical (Medical Devices) must have expert knowledge of relevant laws, regulations, and guidance in this area; as well as demonstrated success in technically evaluating scientific data on medical device products and strategically advising on appropriate development.
To serve as a luminary in Regulatory Consulting, a Technical VP must have a thorough understanding of the organizationÂs consulting models and methodologies, as well as extensive knowledge of what services RCS provides. A Technical VP provides a full range of consulting services and works within their personal area of expertise. A Technical VP provides mentoring and guidance to other RCS employees and leads knowledge-centered activities within RCS. A Technical VP participates in the development of new service offerings, consulting models and methodologies.
Job responsibilities include:
Project Execution
 Works within a team environment or individually based on the project needs
 Works within broad project guidelines and leads issue and conflict resolutions
 Prioritizes own workload and prioritizes the workload of the project team to achieve the project scope and objectives
 Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
 Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
 Produces quality work that meets the expectations of Regulatory Consulting (RC) and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RC are met
 Manages project engagements (small or large)
 Interacts with the assigned Project Leader to ensure accurate financial management and for general project support
 Provides guidance to project team members and acts as a mentor to junior staff
Thought Leadership
 Frequently presents speeches or seminars to industry groups based on recognized expertise in his/her field
 Frequently authors articles for publication in industry magazines, newsletters, book chapters and other forums
 Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of Regulatory Consulting are met
 Regularly quoted by general and industry news outlets
 When applicable, serves as a leading member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more professional associations
 Contributes expertise to professional societies, academic or other similar groups influential in his/ her area of expertise
 Reinforces the knowledge-centered activities within Regulatory Consulting based on their own knowledge and expertise
 Facilitates improvements to the Parexel business processes
 Facilitates new service and consulting model development
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Consulting Activities and Relationship Management
 Adapts the appropriate organizationÂs consulting models and methodologies when unique situations present themselves as well as designs//improves the methodologies when needed
 Provides a full range of technical and/or business consulting services across multiple disciplines of services including representing clients to regulatory agencies
 Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction
 Acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined
 Acts as a loaned executive for a client when required
 Facilitates resolutions to possible problems or conflicts within the project team and/or the client
 Provides guidance as needed to junior colleagues on appropriate methods of executing project activities
 Develops and implements business solutions addressing specific client needs using expertise, best practices and knowledge of the clientÂs business and key industry drivers
 Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization. Presents to client boards and provide strategic advice to the C suite
 Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and builds relationships which results in additional business or referrals
 Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RCS management and account management
Requirements
 Education - PhD required
 Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in developing key device products such as: companion diagnostics, combination drug-device products, software as a medical device, women's health products (e.g., IUDs), etc. Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Review Officer, Team Lead, etc. or a related Supervisory Review role is strongly preferred, but SMEs with Industry experience will also be considered
 The ability to travel up to 20-30% domestically and/or internationally may be required for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance
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