Director, Regulatory Affairs

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 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. 
• 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.

Behaviors:

• Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

Supervisory Responsibilities:

• This position will have supervisory responsibilities.

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.