Director, Regulatory Affairs

Summary

Join RQM+, a MedTech CRO, as the Director, Regulatory Affairs, a highly respected, technically accomplished individual contributor and team leader. This role combines deep regulatory (and/or reimbursement expertise) with operational savvy and a strong industry presence. You will contribute billable expertise, mentor junior team members, collaborate cross-functionally, and advance the team’s strategic vision. You will help the team scale, increase profitability, and expand into new regulatory domains. Serve as a client-facing subject matter expert, contribute to marketing initiatives, and play a key role in resource planning and internal capability building. This position offers supervisory responsibilities and opportunities for professional growth within a supportive and values-driven organization.

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)
• 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
• 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
• Willingness to travel up to 25%, with peaks as needed for client or internal engagements
• Flexibility in work schedule to support client needs across time zones

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
• Create and demonstrate positive morale among project team members; monitor and proactively address team dynamics and areas of concern
• Support and coach employees in the My performance process to drive employee ownership in goal setting, feedback, recognition, and development planning

Preferred Qualifications

• Ex or current FDA preferred
• Prior consulting experience strongly preferred

Benefits

• Industry leading compensation package
• Focus on work life balance