- Serve as subject matter expert and lead instructor providing highly complex and expert guidance to clients globally and region-ally.
- Manage a discrete portfolio of clients and services to meet specific targeted value as identified by managing director.
- Assess client needs and formulate client solutions, constantly innovating, refining and improving these services throughout the consulting lifecycle.
- Presenting to executive management
- Oversee consulting projects during delivery, including:
- Act as the direct liaison between the clients and NSF,
- Provide guidance and mentoring to junior level consultants, and
- Provide overall project management of targeted actions and deliverables, and
- Provide team leadership on active projects for subordinate team members and reports progress to clients and NSF leadership.
- Promote Health Sciences consulting and training services through thought leadership, marketing, public speaking, training, conferences, events, and working group representation domestically and internationally.
- Partner with relevant stakeholders to identify and introduce client driven services within the field of expertise.
- Participate in the selection and approval of both internal and external trainers and/or consultants within area of expertise.
- Train, develop, and direct consultants and expert instructors.
- Leverage existing relationships to expand product and service acceptance.
- Ensure transparent communication to project team and clients.
- Apply continuous improvement principles to innovate, refine and improve across the consulting lifecycle.
- Participate in the execution, management and supervision of billable work
- Excellent presentation skills; ability to interpret and present highly complex and strategically significant information
- MASTERY knowledge of regulations and guidance related to the products within the portfolio of services. Including strong knowledge specifically in US FDA regulations and guidance.
- Previous employment experience at US FDA, Notified Body or equivalent
- Strong Communication Skills, both written and verbal.
- 5+ years' leading cross-functional teams.
- 5+ years' senior project management experience.
- 4 yr Degree (preferred in the Health Sciences/Technology fields)
- Preferred Qualifications:
- Medical Device or In vitro Diagnostic (IVD) Industry experience, examples of specific experience include Regulatory Affairs, Quality Assurance, Manufacturing.
- Experience providing medical devices or IVD consulting, training, clinical research design, development or support; or equivalent experience.
- Recognized as an industry/regulatory expert in one or more service lines / product lines associated with the strategic growth of NSF Health client base.
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Senior Consultant Medical Device - Ann Arbor, United States - NSF
Description
Job DescriptionThe Senior Consultant Medical Device acts as a subject matter expert in the delivery of consulting and/or training engagements. The Senior Consultant Medical Device has direct project oversight responsibility acting as the project leader. This position partners with the Consultant Business Lead and Operations personnel to develop, drive and deliver high quality consulting and training products and services.
Responsibilities
Key Job Responsibilities:
Qualifications - External
