GSS Principal Regulatory Affairs Specialist, Intelligence & Strategy

Hologic

13h•$116,000 - $182,000•Remote

About The Position

The Principal Regulatory Intelligence & Strategy Specialist serves as a senior individual contributor and subject‑matter expert responsible for proactively monitoring, interpreting, and operationalizing global regulatory intelligence to inform regulatory strategy, enhance organizational readiness, and drive continuous improvement across the Surgical Division. This role ensures regulatory processes, practices, and decision‑making remain aligned with the state of the art, evolving regulatory expectations, and business objectives. The position plays a critical advisory role across product development, lifecycle management, quality systems, and divisional operations by translating regulatory change, audit intelligence, and compliance signals into actionable insights. The Principal Specialist influences regulatory capability, supports advocacy efforts, strengthens audit readiness, and partners with teams across the organization to ensure regulatory strategy is embedded early and effectively in both product and non‑product activities. Partner with Corporate and other Divisional leaders, you will represent the Surgical Division to Lead and manage the Regulatory Intelligence (RI) process, ensuring timely identification, assessment, documentation, and communication of external regulatory changes, standards updates, guidance documents, and health authority expectations. Analyze regulatory intelligence to determine business, compliance, and operational impact, translating complex requirements into practical guidance for regulatory and cross‑functional teams. Maintain divisional awareness of emerging regulatory trends and anticipate potential risks or opportunities impacting product development, market access, and lifecycle activities. Ensure regulatory interpretations and processes consistently reflect the current state of the art and regulatory best practices across global markets.

Responsibilities

Lead and manage the Regulatory Intelligence (RI) process, ensuring timely identification, assessment, documentation, and communication of external regulatory changes, standards updates, guidance documents, and health authority expectations.
Analyze regulatory intelligence to determine business, compliance, and operational impact, translating complex requirements into practical guidance for regulatory and cross‑functional teams.
Maintain divisional awareness of emerging regulatory trends and anticipate potential risks or opportunities impacting product development, market access, and lifecycle activities.
Ensure regulatory interpretations and processes consistently reflect the current state of the art and regulatory best practices across global markets.
Track, trend, and evaluate regulatory deficiencies, non‑conformities, audit observations, and inspection findings to identify systemic themes and improvement opportunities.
Partner with Regulatory Affairs, Quality, and divisional stakeholders to drive process improvements, standardization, and effectiveness enhancements informed by regulatory intelligence and audit outcomes.
Support and contribute to CAPA activities, including investigation support, root cause analysis input, corrective and preventive action development, and effectiveness checks.
Act as a key contributor to strengthening regulatory operational excellence and sustained compliance within the Surgical Division.
Provide regulatory strategic guidance to NPD feasibility and early development activities, including classification considerations, regulatory pathways, data expectations, and potential regulatory risks.
Support upstream regulatory decision‑making to enable informed trade‑offs between compliance, innovation, timelines, and business objectives.
Advise cross‑functional teams on regulatory considerations impacting technology selection, intended use, labeling concepts, and clinical or non‑clinical evidence strategies during early development phases.
Support regulatory advocacy activities, including monitoring policy initiatives, participating in industry forums or working groups, and contributing to internal positions on evolving regulatory topics as requested.
Provide technical input and background intelligence to support organizational engagement with trade associations, consortia, or regulatory authorities.
Act as a knowledgeable internal resource on global regulatory policy topics relevant to surgical medical devices.
Identify regulatory training needs within the Regulatory Affairs function and across the Surgical Division, informed by regulatory intelligence, audit learnings, observed performance gaps, and change initiatives.
Develop or support regulatory‑led divisional training content, awareness sessions, and knowledge‑sharing activities to enhance regulatory literacy and compliance maturity.
Promote consistent application of regulatory expectations through guidance, tools, and learning mechanisms that support sustainable compliance.
Support internal audits, external audits, inspections, and health authority or Notified Body interactions, as applicable to regulatory intelligence, processes, or divisional readiness.
Provide subject‑matter expertise during audit preparation, execution, response development, and follow‑up activities.
Contribute insight into regulatory expectations, trends, and inspection focus areas to enhance organizational preparedness and response quality.
Act as a thought leader within Regulatory Affairs by shaping how regulatory intelligence is collected, evaluated, and embedded into decision‑making.
Mentor and coach regulatory colleagues informally by sharing expertise, best practices, and lessons learned.
Contribute to the development, refinement, and governance of regulatory procedures, tools, and frameworks related to intelligence, strategy, and compliance monitoring.
Maintain awareness of evolving regulatory science, digital tools, and intelligence methodologies that improve efficiency and insight generation.
Represent Regulatory Affairs in cross‑functional initiatives where regulatory foresight and strategic interpretation are critical to success.