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Job Description
Join Cepheid as the Director of Clinical Quality and Compliance to lead compliance strategies and ensure adherence to regulatory standards. This remote role offers the chance to significantly impact global health care through innovative diagnostic solutions while fostering career development.
Key Responsibilities
Develop and oversee a global clinical affairs compliance strategy and program
Provide leadership to managers and professional associates
Ensure SOPs and clinical templates are compliant with international regulations
Oversee compliance for manuscripts and scientific communications
Evaluate and implement systems for Clinical Affairs activities
Collaborate with new product development and post-market surveillance teams
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 and trust 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
Benefits & Perks
Comprehensive benefits package including paid time offMedical/dental/vision insurance401(k)Bonus/incentive pay