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Job Description
Join Cepheid as the Director of Clinical Quality and Compliance, where you will drive compliance strategies within Clinical Affairs, ensuring adherence to global regulations. This remote role offers a chance to lead a team and contribute to innovative diagnostic solutions that improve patient outcomes worldwide.
Key Responsibilities
Develop and oversee the design and execution of a global clinical affairs compliance strategy
Provide leadership to managers and professional associates
Maintain compliance of Clinical Affairs SOPs and clinical templates
Ensure compliance with review processes for manuscripts and scientific communications
Evaluate and implement systems to support Clinical Affairs activities
Collaborate with new product development and post-market surveillance stakeholders
Required Qualifications
Bachelor's degree in science with 14+ years of clinical quality/GCP experience within the device industry
Master's degree in science with 12+ years of clinical quality/GCP experience within the device industry
Knowledge of US requirements and regulations related to Good Clinical Practice
Proven track record of managing successful clinical audits
Ability to build strong relationships with global stakeholders
4+ years managing people
Preferred Qualifications
Understanding of IVD regulations for other geographies (e.g., Asia, Africa, and Latin America)
FDA audit (e.g., BIMO) process experience
Benefits & Perks
Comprehensive medical/dental/vision insurance401(k)Paid time offBonus/incentive pay