Verified Expertise

Regulatory Authority.
Global Heritage.

Beacon Regulatory Services LLC is led by senior executives and principal consultants with more than two decades of combined experience directing global regulatory affairs, quality strategy, and market authorization activities for some of the world’s most established and regulated medical device organizations. Our leadership team has operated at scale—inside multinational manufacturers, across diversified product portfolios, and within complex matrixed environments—bringing institutional rigor, operational discipline, and executive judgment to every client engagement.
Representative Leadership & Consulting Experience
Abbott
Baxter
Cook Medical
Johnson & Johnson
Integra LifeSciences
 

Executive Background

Senior Leadership Heritage
Our executives have held senior and site-level leadership roles with direct accountability for global regulatory strategy, post-market compliance, and executive decision support—managing enterprise portfolios across Abbott, Baxter, and Johnson & Johnson while partnering closely with quality, R&D, manufacturing, and commercial leadership.
Enterprise Consulting Oversight
Beacon’s consulting leadership has directed complex Class II and Class III regulatory programs, including high-risk submissions, remediation initiatives, and cross-functional recovery efforts for Cook Medical, Integra LifeSciences, and comparable global manufacturers operating under FDA and EU MDR scrutiny.
 

Technical Standards

Regulatory Affairs Certification (RAC)
Our leadership includes RAC-credentialed professionals and long-standing members of the Regulatory Affairs Professionals Society, reflecting sustained mastery of U.S. FDA frameworks, international harmonization, and evolving regulatory expectations.
Doctoral-Level Standing
Beacon Regulatory Services is grounded in doctoral- and graduate-level regulatory science, public health, and policy training, including advanced degrees in regulatory affairs from the University of Pennsylvania—ensuring analytical depth, strategic clarity, and executive-grade advisory output.
 
 

Submission & Interface Authority

Beacon’s senior leadership maintains direct, hands-on engagement with regulatory authorities worldwide. We routinely serve as the executive interface to the FDA, Notified Bodies, and competent authorities—defending technical positions, leading high-stakes regulatory interactions, and guiding clients through critical decision points that materially affect market access and enterprise risk.

  • Executive-level leadership for FDA Pre-Submissions (Q-Subs) and strategic meetings.
  • End-to-end governance of FDA GUDID and EUDAMED registrations and maintenance.
  • Strategic oversight of Clinical Evaluation Reports (CERs) and clinical evidence strategy.
  • Enterprise vigilance, complaint handling, and MDR compliance under 21 CFR 803.
Regulatory Footprint
20+
Years of senior industry experience
Global
United States, Canada, EU, UK, Mexico
Class III & II
Medical device portfolios

Enterprise Knowledge. Boutique Speed.

Beacon Regulatory Services LLC brings the governance discipline, analytical rigor, and risk awareness of billion-dollar product organizations to focused, high-touch client engagements. We combine executive accountability with operational agility—eliminating bureaucratic drag while delivering audit-ready, regulator-credible outcomes.

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