Principal Regulatory Consultant

RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.
We don’t make MedTech. We make MedTech happen.
Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency
The Principal is responsible for the delivery of service offerings. The Principal ensures the delivery of regulatory and quality solutions that are best practice and innovative to enable client success through delivery of superior service. The Principal leads the delivery of regulatory and quality solutions to enable client success. The role is responsible for directing and advising others in the development of work products and the execution of the defined consulting scope of work.

Primary Responsibilities:

• Ensure employee cultural connection and engagement across project(s), in alignment with the overall RQM+ values and culture statement; Lead efforts to leverage strengths, better understand gaps, and identify and implement engagement solutions.
• Provides timely and relevant communication to both internal and external stakeholders. This may include weekly project updates, anticipation of future resourcing needs, large client multi-year program reviews, etc.
• Understands/interprets global regulatory requirements and leads daily regulatory and quality hands- on support to clients by providing best practice and innovative solutions.
• Leads projects to ensure the customer is 100% satisfied with the project, fully communicated with, and that any issues are predicted prior to them arising. Must be able to understand the customer satisfaction level of the project at any given time.
• Consulted on changes related to technical strategy, content, and quality of deliverables to meet client needs and expectations.
• May act as the primary point of contact for client projects and specific deliverables, working to understand challenges, weigh the risks, and determine the appropriate business-balanced solution and path forward with the client.
• May serve as an individual contributor and/or reviewer on projects.
• Provides constructive and solution-oriented feedback and suggestions on training processes and templates to Technical Leaders within RQM+. May maintain, update, or create training, processes, and templates for RQM+ or client.
• May review statements of work to ensure technical requirements and risks are adequately covered and addressed for client portfolio or specific practice areas.
• Contributes regulatory intelligence to technical leaders within RQM+.
• Identifies and escalates risks to RQM+ business and reputation as needed to the appropriate stakeholders.
• May support sales calls to ensure technical representation is available to properly understand and discuss client needs.
• Demonstrated ability to apply the skill to solve complex, multifaceted and/or recent problems, and can apply their knowledge and skill to customize solutions to specific requirements in a collaborate manner.
• Find ways to improve coordination of work in progress, and utilization of staff within and across teams, and exercise leadership in a collaborative way.
• Enable the development of a positive team environment, balancing individual initiative with team collaboration, and with RQM+ priorities.
• Works on special projects and other duties as assigned.

Requirements:

• Bachelor level degree in a related field required.
• Minimum 5 years' experience in the medical device industry required, with a minimum of 7 years' work experience required.
• Previous experience at the FDA-CDER or FDA-CBER preferred.
• Has managed, led, and developed people in achieving organizational goals.
• Previous consulting experience, preferred.
• Advanced computer skills including Microsoft business applications.
• Experience managing or providing oversight for one or more complex programs required.
• Keen understanding of the RQM+ business, organization roles and responsibilities, the internal quality system, and operating systems and how to effectively maneuver within each preferred.
• Establishes and maintains effective relationships with customers and gains their tru