[Hiring] Principal Regulatory Affairs Specialist, Intelligence & Strategy @Hologic
Role Description
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.
• Play a critical advisory role across product development, lifecycle management, quality systems, and divisional operations.
• Translate regulatory change, audit intelligence, and compliance signals into actionable insights.
• Influence regulatory capability, support advocacy efforts, strengthen audit readiness, and partner with teams across the organization.
• Represent the Surgical Division to lead and manage the Regulatory Intelligence (RI) process.
• Ensure 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.
• Maintain divisional awareness of emerging regulatory trends and anticipate potential risks or opportunities.
• Ensure regulatory interpretations and processes consistently reflect the current state of the art and regulatory best practices across global markets.
Qualifications
• Experience in regulatory affairs, particularly in the medical device industry.
• Strong understanding of global regulatory requirements and standards.
• Excellent analytical and problem-solving skills.
• Ability to communicate complex regulatory concepts clearly.
• Proven track record of influencing cross-functional teams.
Requirements
• Track, trend, and evaluate regulatory deficiencies, non-conformities, audit observations, and inspection findings.
• Partner with Regulatory Affairs, Quality, and divisional stakeholders to drive process improvements.
• Support and contribute to CAPA activities, including investigation support and root cause analysis.
• Provide regulatory strategic guidance to NPD feasibility and early development activities.
• Advise cross-functional teams on regulatory considerations impacting technology selection and evidence strategies.
• Support regulatory advocacy activities and provide technical input for organizational engagement.
• Identify regulatory training needs and develop training content to enhance regulatory literacy.
• Support internal audits, external audits, inspections, and health authority interactions.
• Act as a thought leader within Regulatory Affairs and mentor regulatory colleagues.
Benefits
• Annualized base salary range of $116,000 to $182,000, bonus eligible.
• Final compensation packages depend on relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
Company Description
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.
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.
• Play a critical advisory role across product development, lifecycle management, quality systems, and divisional operations.
• Translate regulatory change, audit intelligence, and compliance signals into actionable insights.
• Influence regulatory capability, support advocacy efforts, strengthen audit readiness, and partner with teams across the organization.
• Represent the Surgical Division to lead and manage the Regulatory Intelligence (RI) process.
• Ensure 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.
• Maintain divisional awareness of emerging regulatory trends and anticipate potential risks or opportunities.
• Ensure regulatory interpretations and processes consistently reflect the current state of the art and regulatory best practices across global markets.
Qualifications
• Experience in regulatory affairs, particularly in the medical device industry.
• Strong understanding of global regulatory requirements and standards.
• Excellent analytical and problem-solving skills.
• Ability to communicate complex regulatory concepts clearly.
• Proven track record of influencing cross-functional teams.
Requirements
• Track, trend, and evaluate regulatory deficiencies, non-conformities, audit observations, and inspection findings.
• Partner with Regulatory Affairs, Quality, and divisional stakeholders to drive process improvements.
• Support and contribute to CAPA activities, including investigation support and root cause analysis.
• Provide regulatory strategic guidance to NPD feasibility and early development activities.
• Advise cross-functional teams on regulatory considerations impacting technology selection and evidence strategies.
• Support regulatory advocacy activities and provide technical input for organizational engagement.
• Identify regulatory training needs and develop training content to enhance regulatory literacy.
• Support internal audits, external audits, inspections, and health authority interactions.
• Act as a thought leader within Regulatory Affairs and mentor regulatory colleagues.
Benefits
• Annualized base salary range of $116,000 to $182,000, bonus eligible.
• Final compensation packages depend on relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
Company Description
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.