Quality Director Post Market Surveillance
By Abbott At Alameda, CA, United States
Utilizes technical/professional knowledge and skills to establish, interpret and execute company policies in a major segment of the company.
Bachelor's degree and 10+ years of related work experience or an equivalent combination of education and work experience. Advanced degree preferred
Provides general direction to managers, exempt specialists and non-exempt support in various areas, groups and/or operations
Establish Quality Systems that are in compliance with regulatory requirements and meet business needs
Career development with an international company where you can grow the career you dream of
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
Post Market Quality Operations Manager
By Juul Labs At , San Francisco, Ca
3+ years of Quality Management Systems (QMS) Experience
American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is preferred
Timely communication of business-related issues or opportunities to the next management level
Maintain knowledge of current global regulations impacting Post Market Surveillance activities
Apply knowledge to develop and optimize processes and suggest improvements as needed and/or required
Additional responsibilities may be assigned

Are you looking for an exciting opportunity to lead post-market studies and help shape the future of healthcare? We are looking for a Post Market Studies Manager to join our team and help us develop and execute post-market studies to ensure the safety and efficacy of our products. You will be responsible for managing the design, implementation, and analysis of post-market studies and will have the opportunity to collaborate with a diverse team of experts. If you are a strategic thinker with a passion for healthcare, this is the perfect job for you!

Overview The Post Market Studies Manager is responsible for the design, implementation, and analysis of post-market studies to assess the safety, efficacy, and performance of medical devices. This role requires a strong understanding of the medical device industry, regulatory requirements, and clinical research. The Post Market Studies Manager will work closely with internal and external stakeholders to ensure that post-market studies are conducted in accordance with applicable regulations and standards. Detailed Job Description The Post Market Studies Manager will be responsible for the design, implementation, and analysis of post-market studies to assess the safety, efficacy, and performance of medical devices. This role requires a strong understanding of the medical device industry, regulatory requirements, and clinical research. The Post Market Studies Manager will work closely with internal and external stakeholders to ensure that post-market studies are conducted in accordance with applicable regulations and standards.

The Post Market Studies Manager will be responsible for:

• Developing and implementing post-market studies to assess the safety, efficacy, and performance of medical devices
• Designing and executing post-market studies in accordance with applicable regulations and standards
• Analyzing and interpreting data from post-market studies
• Developing and maintaining relationships with internal and external stakeholders
• Ensuring that post-market studies are conducted in a timely and cost-effective manner
• Preparing reports and presentations to communicate study results
Job Skills Required
• Knowledge of medical device industry and regulatory requirements
• Knowledge of clinical research and study design
• Ability to analyze and interpret data
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Strong organizational and project management skills
• Proficiency in Microsoft Office
Job Qualifications
• Bachelor’s degree in a related field
• 5+ years of experience in medical device industry
• 5+ years of experience in clinical research
• Experience in post-market studies
• Certification in Good Clinical Practice (GCP)
Job Knowledge
• Knowledge of medical device industry and regulatory requirements
• Knowledge of clinical research and study design
• Knowledge of post-market studies
• Knowledge of Good Clinical Practice (GCP)
Job Experience
• 5+ years of experience in medical device industry
• 5+ years of experience in clinical research
• Experience in post-market studies
Job Responsibilities
• Developing and implementing post-market studies