Principal Regulatory Consultant

Primary Responsibilities:

Client Leadership & Project Delivery

Serve as the lead regulatory consultant for client engagements, ensuring delivery of high-quality, actionable, and compliant solutions tailored to global regulatory expectations.

Act as the primary point of contact for select client projects, managing technical strategy, regulatory content, and project quality to drive client satisfaction and long-term partnership.

Anticipate client needs, communicate proactively, and troubleshoot challenges before they escalate.

Strategic Regulatory Expertise

Interpret and apply global regulatory requirements (FDA, EMA, global bodies) across a wide range of product types, including devices, diagnostics, and combination products.

Provide hands-on regulatory guidance, contribute to cross-functional strategy, and shape client submissions, technical files, and quality system compliance.

Bring regulatory intelligence and foresight to complex challenges, offering innovative and business-aligned solutions.

Leadership & Collaboration

Mentor and guide junior consultants; foster a high-performance team environment rooted in accountability, collaboration, and continuous learning.

Collaborate with internal stakeholders to optimize resource utilization across active and upcoming projects.

Contribute to internal process improvements, including training, templates, and technical best practices.

Business & Growth Support

Support business development by participating in client discussions and proposals to ensure strong technical alignment and accurate scoping of work.

Review statements of work to ensure technical feasibility and strategic alignment.

Identify risks to client success or RQM+ reputation and escalate as appropriate.

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 trust and respect.

Strong Business Acumen, with the ability to think strategically and respond appropriately to customer needs.

Ability to manage in a matrix environment.

Project management and creative leadership skills including the demonstrated ability to lead multiple, simultaneous projects to resolve issues and achieve results in a timely and effective manner.

High performance orientation, a detail orientation, and strong organization skills.

Proficiency in time management and communication to achieve business goals.

Excellent interpersonal, communication and influencing skills and experience working with clients, employees, and outsiders.

Knowledge of contracting, negotiating, and change management.

Ability to develop and deliver presentations, professional written and verbal communication, and interpersonal skills.

Ability to communicate and interact with business leaders across all levels.

Ability to motivate teams and simultaneously manage several projects.

Requires willingness to work a flexible schedule and travel at least 25% of the time with spikes as required to ensure customer satisfaction.

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.

Consulting services is focused on creating a culture of respect and continuous improvement with the aim of generating maximum value for customers and stakeholders by identifying value and eliminating waste in processes.

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 may 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.