Remote Senior Director, Regulatory Intelligence & FDA Engagement

Ladders; United States; Remoto; USD 203.000 - 305.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Continuing education and training

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Regulatory leadership

FDA engagement

Cross-functional leadership

Regulatory strategy

Formazione

Bachelor’s degree in Regulatory Affairs / Life Sciences

Descrizione del lavoro

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.