Sr Dir Regulatory Intelligence & FDA Engagement
Medline Industries, LP · United States · US
Regulatory Affairs
Remote
Not yet analysed
Demand68
Career growth62
Healthcare fit42
Remote potential35
Salary band
USD 203k – 305k
5-year outlook
Senior director-level regulatory leadership roles generally sit in executive compensation bands, with stability tied to FDA enforcement activity and portfolio complexity. Exact salary figures are not provided in the posting.
Clinical license
Not required
Applicant reach
narrow
Seniority
executive
Employment type
full-time
Date found
2026-11-08
Intelligence details
Flexible work details
- Engagement type
- Permanent
- Hours
- Full-time
- Eligible countries
- United States
- Rate period
- Annual
Listing via Himalayas.
Eligibility, licensing, and location restrictions can change. Always confirm details on the source posting before applying.
Why this is worth applying to
Only worth applying if you already have deep regulatory affairs/quality leadership and direct FDA enforcement-response experience. Most clinicians would be underqualified unless they have completed a prior transition into regulatory leadership.
Who should apply
Senior regulatory affairs or quality leaders in medical devices, pharmaceuticals, biologics, or combination products with direct FDA 483/Warning Letter response authorship; clinicians who have already moved into regulatory leadership roles.
CV angle
Frame real experience with regulatory submissions, inspections, FDA/health-authority interactions, 483/Warning Letter responses, risk assessments, cross-functional governance, and remediation plans. Quantify portfolio scope and compliance outcomes without inventing regulatory leadership experience.
Skills to highlight
- Regulatory intelligence
- FDA engagement
- FDA Form 483 and Warning Letter responses
- Regulatory affairs strategy
- Quality and compliance leadership
- Risk assessment and remediation
- Cross-functional governance
- Global health authority interactions
Role summary
A senior regulatory leadership role responsible for building enterprise regulatory intelligence, monitoring global regulatory changes, assessing business and compliance risk, and leading FDA engagement and enforcement responses across medical devices, pharmaceuticals, combination products, and related portfolios.
We publish our own intelligence summary, never the full job description. Always confirm details with the employer when you apply.