Quality and Compliance Director – Medical Industry

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🕒 April 15

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Keller Executive Search International

WebsiteLinkedInAll Job Openings

11 - 50 employees

🎯 Recruiter

👥 HR Tech

Recruitment • HR Tech • Professional Services

Keller Executive Search International is a global executive search firm specializing in helping organizations find exceptional leadership talent. With a network spanning numerous cities around the world, they provide recruitment services, transition planning, employee coaching, and leadership development. Committed to diversity and sustainability, Keller offers high-quality, tailored executive search solutions across various industries. Their services include recruitment process outsourcing, military transitions, and succession planning, with a focus on finding the right leaders to drive business success globally. Keller is recognized for its robust assessment practices and a comprehensive suite of HR advisory services.

📋 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.