The Regulatory and Quality Director is responsible for providing regulatory and quality solutions to medical device and combination product clients in their territory. This position is responsible for ensuring a presence in the territory and will participate in the marketing initiatives for in their defined territory, . They also may lead or directly contribute to consulting engagements in their territory, particularly Tier 2-4 clients, and will manage designated resources and ensure overall customer satisfaction. Additionally, this role is also focused on team member growth and development and is keenly focused on ensuring team members are meeting expectations and are thriving in their role and at R&Q in general. As an expert in regulatory and quality, the Director of Territory Operations may lead and have overall accountability for an aspect of our Center of Excellence knowledge wheel as it relates to training and development opportunities and offering coaching to less experienced consultants as a subject matter expert.
- Provide the local R&Q presence and become engrained in the medical device and combination community in the territory; become known within the region as the go-to person in the regulatory and quality space.
- Leads the customer interface with the client providing overarching customer contact and leadership.
- Oversees territory operations to ensure production efficiency, quality, service, and cost-effective management of resources.
- Customer lead with R&Q ensuring the customer is 100% satisfied, fully communicated with, and issues are predicted prior to them actually arising. Must be able to understand the customer satisfaction level of the client at any given time.
- Ensures that projects for which they have accountability, are on schedule and hitting cost targets, profit margin, and in compliance with the R&Q Quality Management System.
- Has input into and participates in marketing plans and events in the territory.
- Manages team members to ensure services are performed for clients in an effective and efficient manner.
- Assists with the implementation of the Staffing Plan by partnering with the VP of Operations and Resource Manager to add additional resources to the territory.
Center of Excellence Lead/SME:
- Responsible for the review, approval and the on time completion of Center of Excellence training materials and R&Q templates for their assigned R&Q Knowledge Area.
- Provides support for calls for assistance on billable projects.
- Responds to questions from sales/sales ops engineer to technically review proposed projects, estimate sheets and help determine deliverables and hours to be allocated to projects.
- Functions as the first choice in their R&Q Knowledge Area to be the independent reviewer for deliverables.
- Bachelor level degree in engineering or a technical field required; advanced degree preferred.
- Minimum 10 years’ experience in the medical device industry required, with a minimum of 15 years work experience required.
- Minimum 5 years of medical device consulting experience, required.
- Experience representing quality and regulatory on new product development teams, highly preferred.
- Experience working on Standards Committees, FDA Working Groups, and well networked in the regulatory community, highly preferred.
- Advanced knowledge in two or more of the following areas and general knowledge of all areas is required:
- Quality System Regulations (FDA, ISO13485, EU Medical Devices Directive, Canadian MDR)
- Market Clearance and strategy (510K, EU Technical Files, Canadian licensing)
- Design controls, DHF Development, and related standards especially International Electrical Safety, Biocompatibility, and ISO 10993 Software Development and Validation per EN 62304
- Design Verification and Design Validation
- Safety and risk management per ISO 14971
- Usability per ISO 62366 and other Human Factors Standards
- Process Validation
- Advanced computer skills including business applications, statistical data analysis and report writing required.
- One or more of the following preferred: Regulatory Affairs Certification (RAC), CQA/CQE/Certified Lead Auditor Training.
Focuses on customer, plays well with others, takes responsibility, ambition and drive, reading the situation, acts decisively, ensures results, adapts quickly, influences others, builds trust, business/financial acumen, change management.