Sr Dir Regulatory Intelligence & FDA Engagement

Ladders; United States; Remote; USD 203,000 - 305,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Continuing education and training

Job summary

Ladders seeks a Sr Dir Regulatory Intelligence & FDA Engagement to lead the global regulatory intelligence function in the Healthcare space. This senior leader will partner with executive leadership to assess regulatory changes, drive action plans, and support remediation.

Remote work is possible with exposure to health authorities and cross-functional teams. The role emphasizes directing governance, authoring agency responses, and guiding teams through negotiations in highly regulated markets.

Qualifications

• Bachelor’s degree in regulatory affairs or life sciences required.
• 10+ years progressive regulatory affairs/quality leadership experience.
• 8+ years interacting with global health authorities.
• Experience in regulated healthcare industries (devices, pharma, combination products).
• Direct authorship of FDA-483s and agency responses.

Responsibilities

• Develop and execute the global regulatory intelligence strategy.
• Direct enterprise-wide impact assessments for regulatory changes.
• Coordinate cross-functional action plans and executive escalations.
• Establish governance, policies, procedures, and metrics for regulatory intelligence.
• Identify regulatory trends and advise leadership on business impact.
• Lead responses to FDA observations and regulatory actions.
• Guide teams through regulatory negotiations and remediation.

Skills

Regulatory leadership

FDA engagement

Cross-functional leadership

Regulatory strategy

Education

Bachelor’s degree in Regulatory Affairs / Life Sciences

Job description

For our client, we are seeking a Sr Dir Regulatory Intelligence & FDA Engagement to join the team of a leader in the Healthcare space.

This senior leader will shape the enterprise regulatory intelligence function and ensure the organization is prepared to respond effectively to shifting global requirements. The role will partner closely with executive leadership and cross-functional teams to assess regulatory change, drive action plans, and support timely remediation. It will also guide external engagement with health authorities and help protect the business across highly regulated healthcare markets.

Location: Remote

Compensation: $203,000 – $305,000 annually

Responsibilities

• Develop and execute the global regulatory intelligence strategy
• Direct enterprise-wide impact assessments for significant regulatory changes
• Coordinate cross-functional action plans and executive escalations
• Establish governance, policies, procedures, and metrics for regulatory intelligence activities
• Identify emerging regulatory trends and advise leadership on potential business impacts
• Lead preparation of responses to FDA observations and regulatory actions
• Guide cross-functional teams through regulatory negotiations and remediation activities

Qualifications

• Bachelor's degree in Regulatory Affairs, biology, microbiology, biomedical engineering, pharmaceutical science, chemistry, life sciences, or a related field
• 10+ years of progressive Regulatory Affairs and/or Quality leadership experience
• 8+ years interacting directly with global health authorities
• Significant experience in highly regulated healthcare industries, including medical devices, pharmaceuticals, and combination products
• Direct authorship of multiple FDA-483/Warning Letters and other responses to regulatory agencies

Benefits

• Health insurance
• Life and disability insurance
• 401(k) contributions
• Paid time off
• Continuing education and training opportunities

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.