Principal Consultant (Medical Device SME) - Home Based

Parexel’s highly recognized Regulatory Consulting Services team is currently seeking a Principal Consultant who is well versed in regulatory strategy and compliance for medical devices! This is an incredible opportunity for an individual who is looking for an opportunity to partner with our clients in the very early stages, use his/her expertise to help our clients develop their strategies, and to guide them along the regulatory pathway. This is an exciting and growing area, and this highly visible, dedicated expert will have the unique opportunity to build and grow this practice, and also serve as the leading voice in this subject area.

As a member of Parexel’s Regulatory Consulting Services Team you will be working with a Team of highly experienced professionals with both Industry and FDA experience; you will have the opportunity to work with a variety of clients and products; you will have the opportunity to find solutions and execute on behalf of our clients; you will have the support of a dedicated Team of Business Development Professionals; and you will have the opportunity to continue to advance professionally and stretch your own thinking.

A Principal Consultant must be a nationally recognized professional in their field of expertise with well-developed and proven rainmaking skills. Must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as, an extensive knowledge of what services PC provides. Provides a full range of consulting services and works within their personal area of expertise. Provides mentoring and guidance to junior team members on technical and/or business issues and supports knowledge-centered activities within Regulatory Consulting. QualificationsConsulting Activities and Relationship Management and Business DevelopmentApplies the appropriate organization’s consulting models and methodologies and assists in the design/improvement the methodologies when neededProvides a full range of technical and/or business consulting services within personal area of expertise including representing clients to regulatory agenciesCompletes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfactionMay act as a trusted advisor to clients, often on issues that lack precedence or are not clearly defined.May act as a loaned executive for a clientFacilitates resolutions to possible problems or conflicts within the project team and/or the client. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activitiesDevelops business solutions addressing specific client needs using expertise, best practices and knowledge of the client’s business and key industry driversDemonstrated ability to interact professionally at multiple levels including senior and executive management within a client organizationPlans and delivers services and solutions which results in clients expressing satisfaction with service provided and occasionally results in additional business or referralsIdentifies opportunities for follow-on business or changes in project scope and exploits the opportunities with PC management and account managementActively prospects and leverages new business opportunities with client and industry contacts in collaboration with Account Management. Presents information about PC service offerings reflecting the organization’s capability to support client needsGenerates new or repeat business due to personal name recognition or history of client satisfaction and/or relationshipLeverages rainmaking skills resulting in new and repeat business for Parexel. Is responsible for constant monitoring of his/her “A” list, and is expected to have continued contact with both existing and future potential clientsParticipates in project scoping calls and proposal preparation, delivers sales presentations and participates in bid defense meetings when needed. Actively participates in account planning for key clients

Education - Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, PhD or other advanced degree

Language Skills - At least fluent vocal and written English

Minimum Work Experience - 10+ years’ medical device subject matter expertise coupled with previous regulatory experience to include a minimum 5 years of experience having authored, submitted and/or reviewed marketing authorization submissions to FDA for medical devices.

Previous experience with a regulatory agency (such as FDA’s CDRH) is preferred, but individuals with strong industry backgrounds will also be considered

Ideally seeking a candidate with the flexibility to work from Parexel’s Bethesda, MD office 2-3 days a week. However, consideration will be given to exceptional candidates in other areas of the United States.

Must have the flexibility to travel @30% domestically and/or internationally.EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.