Quality and Compliance Director – Medical Industry
Keller Executive Search International
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $205,677 - $239,850 per year
Job Level
About the role
- Own clinical evidence strategy and clinical affairs execution across new product development and lifecycle initiatives.
- Define clinical evidence strategies aligned to intended use, labeling objectives, and lifecycle priorities.
- Build integrated evidence plans leveraging the right mix of clinical studies and other appropriate evidence approaches.
- Lead clinical programs with internal stakeholders and external vendors/consultants.
- Ensure compliance, documentation quality, and readiness practices aligned with applicable regulations and standards.
- Partner with cross-functional teams to ensure clinical evidence aligns with product documentation and risk management activities.
- Lead, mentor, and develop a high-performing team; manage performance, development, and partner oversight.
Requirements
- Bachelor’s degree in a scientific, engineering, or related discipline.
- 12+ years in medical devices (or closely related regulated industry), including leadership in Clinical Affairs, Clinical Evidence, or Clinical Strategy.
- Proven ability to lead cross-functional programs in matrixed environments, including multi-region execution.
- Strong working knowledge of regulated development practices and clinical research/quality/risk standards.
- Experience supporting audits/inspections and building sustainable compliance practices.
- Excellent communication skills and executive-level stakeholder management.
- Advanced degree and/or relevant professional certification(s).
- Experience improving clinical operations and enabling systems in global organizations.
Benefits
- $205 677.32 - $239 850.22 base salary (depending on experience)
- Annual performance bonus and long-term incentive opportunity.
- Comprehensive benefits package, including health coverage and retirement savings.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical evidence strategyclinical affairs executionclinical studiescompliance practicesdocumentation qualityrisk managementclinical research standardsquality standardsauditsinspections
Soft Skills
leadershipmentoringteam developmentcommunicationstakeholder managementcross-functional collaborationperformance managementorganizational skillsstrategic planningproblem-solving
Certifications
advanced degreeprofessional certification