<p>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.</p> <p>We don't make MedTech. We make MedTech happen.</p> <p>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.</p> <p>Job Summary:</p> <p>The Vice President, Regulatory, Quality & Reimbursement Services will lead the strategic growth and expansion of the Regulatory, Quality and Reimbursement team within RQM+. This role is accountable for driving all aspects of business performance, including revenue growth, client acquisition, and service delivery excellence. The Vice President will develop and execute targeted go-to-market strategies that align with the evolving needs of the MedTech sector, enhancing sales and marketing effectiveness to capture new opportunities.</p> <p>With deep expertise in the MedTech landscape, the Vice President will ensure RQM+ is competitively positioned in both service offerings and pricing models. This role also includes direct client engagement in a billable capacity-cultivating trusted relationships, identifying high-value opportunities, and delivering impactful solutions that advance our clients' regulatory, quality, and market access objectives.</p> <p>Primary Responsibilities:</p> <ul> <li>Lead the strategic development and implementation of regulatory, quality and reimbursement service offerings to expand and diversify revenue streams. </li><li>Drive business development efforts by securing new client engagements and meeting revenue targets within the regulatory, quality, and reimbursement sector. </li><li>Partner with sales and marketing teams to create and execute strategies that elevate RQM+'s brand visibility and competitive positioning. </li><li>Strategically position RQM+'s regulatory, quality and reimbursement services with a focus on value-driven pricing and differentiated offerings. </li><li>Cultivate and manage strong client relationships by understanding their unique needs, aligning on timelines, and proactively resolving challenges to ensure exceptional satisfaction. </li><li>Build and mentor a high-performing team, fostering both leadership capabilities and technical expertise to support business growth. </li><li>Develop and implement an effective operating delivery model that ensures consistency and scalability; continuously monitoring key metrics and feedback to optimize processes, improve service delivery, and drive long-term success. </li><li>Own overall utilization strategy and partner with Resourcing to ensure alignment with workforce plans and achievement of utilization goals. </li><li>Perform senior review of preparation and submission of regulatory documents (e.g. 510(k), De Novo, PMA, IDE, Technical Files, Design Dossiers, etc.) and provide coaching and feedback to junior staff and to clients when appropriate. </li><li>Oversee reimbursement strategies for clients including payer landscape assessments, coding pathways, coverage strategies and health economic evidence planning. </li><li>Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the client. </li><li>Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement client requests. </li><li>Lead meetings on more challenging topics independently. </li><li>May present on standard regulatory, quality and reimbursement processes at full-service bid defense meetings. </li><li>Assist in the training and development of junior staff, formally as an assigned mentor. May develop and deliver training to the global team on a topic he/she has specific expertise in. </li><li>Complete project finance activities, including monitoring and forecasting budgeted hours. </li><li>Propose, review and approve budgets and costing for all projects, including estimation of hours needed for consulting tasks for regulatory, quality and reimbursement services. </li><li>May take on a small customer lead role or assist an established partnership lead in their role. </li><li>May represent region or site on a regulatory, quality and reimbursement initiative or cross-functional initiative. </li><li>Facilitates and brainstorms the identification of new ideas. May represent Regulatory, Quality and Reimbursement at a general capabilities audit. </li></ul> <p>Education/Work Experience:</p> <ul> <li>Bachelor's Degree in life sciences related discipline or related field, required. Masters/Ph.D. preferred. </li><li>Typically requires at least 15 years of highly relevant experience with a minimum of 5 years in leadership roles. </li><li>Proven experience leading and developing manager-level professionals to successfully achieve organizational objectives. </li><li>Advanced computer skills including Microsoft business applications. </li><li>Experience managing or providing oversight for one or more complex programs, required. </li><li>GCP, FDA and ISO 13485 and 9001 knowledge </li><li>Ability to strategize both emerging and established companies on the development and execution of technical, scientific, pre-clinical, clinical, regulatory and reimbursement strategies. </li><li>Experience with FDA branches such as the Center for Devices and Radiological Health (CDHR) and Center for Biologics Evaluation and Research (CBER) as well as European regulatory bodies. </li><li>In-depth knowledge of global regulatory submission requirements and guidelines for medical devices </li><li>Ability to train internal teams and guide clients on evolving regulatory changes and best practices </li><li>Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner. </li><li>In depth knowledge of device and drug development, reimbursement, and associated regulations as well as quality standards </li><li>Good understanding of medical terminology across a range of therapeutic areas. </li><li>Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and clients. </li></ul> <p>Behaviors: Action-Oriented, Approachability, Political Savvy, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning</p> <p>Requirements:</p> <ul> <li>Strong business acumen, with the ability to think strategically and respond appropriately to leadership, clients, and employee needs. </li><li>Excellent interpersonal, communication and influencing skills as well as experience working collaboratively with business leaders across all levels. </li><li>Effectively lead employees through change by clearly communicating the vision and purpose, involving the employees in the process, addressing concerns, providing support and guidance, modeling the desired behaviors, and continuously monitoring progress. </li><li>Ensure team cultural connection and engagement in alignment with the overall RQM+ values and culture statement. </li><li>Support and coach employees in the My Performance process to drive employee ownership in goal setting, feedback, recognition, and development planning. </li><li>Ensure team members' clarity on expectations and provide regular performance recognition and feedback. </li><li>Ability to lead multiple, simultaneous initiatives to resolve issues and achieve results in a timely and effective manner. </li><li>Demonstrates strong decision quality by relying on a blend of analysis, wisdom, experience, and judgment. Take ownership of decisions and communicates them clearly. </li><li>Requires willingness to work a flexible schedule and travel at least 25% of the time. </li></ul> <p>Supervisory Responsibilities: This position may have supervisory responsibilities.</p> <p>Work Environment/Physical Demands: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds.</p> <p>Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!</p> <p>We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.</p> <p>Job Opportunity Verification</p> <p>At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:</p> <p>All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers</p> <p>Every candidate going through the interview process will participate in a voice and/or video interview.</p> <p>Exercise caution with unsolicited job offers or requests for sensitive information.</p>