Quality and Compliance Director – Medical Industry
Job Description:
• 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.
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• 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.
Apply tot his job
Apply To this Job