GSS Principal Regulatory Affairs Specialist, Intelligence & Strategy

GSS Principal Regulatory Affairs Specialist, Intelligence & Strategy

United States

Louisville, CO, United States

Why Hologic:

Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.

What to expect:

REMOTE OPPORTUNITY

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.

What we expect:

Continuous Improvement & Compliance Signal Management

• 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.

Regulatory Strategy & New Product Development (NPD)

• 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.

Advocacy & External Engagement Support

• 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.

Training, Knowledge Management & Capability Building

• 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.

Audit, Inspection & Health Authority Support

• 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.

Additional Responsibilities Expected at the Principal Level

• 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.

The annualized base salary range for this role is $116,000 to $182,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand..

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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