Director, Regulatory Affairs

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 Director, Regulatory Affairs is a highly respected, technically accomplished individual contributor and team leader within the RQM+ Regulatory Affairs, Reimbursement, Market Access team. This role combines deep regulatory (and/or reimbursement expertise) (preferably across both US and EU markets) with operational savvy and a strong industry presence. The Director will contribute billable expertise while mentoring junior team members, collaborating cross-functionally to meet and exceed utilization goals, and advancing the team’s strategic vision.  The Director is instrumental in helping the team scale smartly, increase profitability, and expand into new and emerging regulatory domains. The Director will serve as a client-facing subject matter expert, contribute to marketing and outreach initiatives, and play a key role in resource planning and internal capability building.

Primary Responsibilities:

• Serve as a highly credible and technically sound regulatory affairs expert with billable project contributions across assigned client portfolios.
• Meet personal utilization targets while helping colleagues achieve theirs through resource collaboration, mentoring, and ideation.
• Provide expert guidance on global regulatory strategies, submission pathways, reimbursement approaches, and related client deliverables.
• Support the operationalization of RQM+’s long-term vision to cover emerging regulatory needs (e.g., combination products, cybersecurity, AI/ML, EU MDR, etc.).
• Assist in building frameworks for process improvement and profitability tracking across consulting projects.
• Lead or co-lead initiatives to identify knowledge gaps, propose training opportunities, and build repeatable consulting infrastructure.
• Contribute to marketing campaigns, co-author thought leadership content and represent RQM+ externally at conferences and events.
• Serve as a strategic partner to Business Development and Resourcing teams to align new project opportunities with internal capabilities.
• Take on direct reports as needed, providing mentorship, development support, and performance coaching.
• Provide timely feedback on consulting and project operations to vertical leadership and contribute to continuous process improvements.

Requirements:

• Bachelor’s degree in a scientific or engineering discipline required; advanced degree preferred.
• Minimum 15 years of experience in the medical device industry with at least 10 in regulatory and/or reimbursement roles.
• Strong working knowledge of US FDA (CDRH, CDER, or CBER) and/or EU regulatory frameworks (MDD, MDR, IVDR)
• Ex or current FDA preferred.
• Demonstrated expertise in developing and executing regulatory strategies across product lifecycle stages.
• Proven ability to operate effectively as both an individual contributor and team leader.
• Experience mentoring team members and/or managing direct reports.
• Strong business acumen with a desire to drive operational efficiency and client success.
• Prior consulting experience strongly preferred.
• Self-motivated, intellectually curious, and confident in complex problem solving.
• Effective communicator and relationship builder across all levels of an organization.
• Creative thinker who can operationalize strategic ideas into scalable team practices.
• Comfortable navigating ambiguity while staying focused on execution and delivery.
• Strong business acumen, with the ability to think strategically and respond appropriately to customer and employee needs.
• Strong alignment with RQM+ values and commitment to client-first excellence.
• Demonstrated ability to collaborate across commercial, technical, and operational functions.
• Ability to motivate teams and simultaneously manage several projects. 
• Self-motivated individual with a “lead by example” approach that endorses the company’s values and culture. 
• Create and demonstr