Chief Regulatory and Quality Counsel
1 week ago
We are seeking a highly experienced Chief Regulatory and Quality Counsel to join our team at Getinge. This is an exciting opportunity for a skilled attorney to take on a leadership role in ensuring compliance with FDA regulations and quality standards.
The ideal candidate will have a strong background in food, drug, and cosmetic law, as well as experience working with medical device companies. They will be responsible for providing legal guidance to business teams, interacting with regulatory agencies, and managing projects related to product submissions, quality system regulations, and manufacturing activities.
This is a challenging and rewarding role that requires a high level of expertise, strong communication skills, and the ability to influence senior management. If you are a motivated and results-driven professional looking for a new challenge, we encourage you to apply.
Key Responsibilities- Provide legal guidance to business teams on FDA regulations and quality standards
- Interact with regulatory agencies to ensure compliance with regulatory requirements
- Manage projects related to product submissions, quality system regulations, and manufacturing activities
- Develop and implement policies and procedures related to quality and regulatory matters
- Collaborate with cross-functional teams to ensure alignment with company goals and objectives
- JD from a nationally recognized institution
- Licensed in good standing to practice law in at least one state and one federal jurisdiction within the United States
- A minimum of 10 years of relevant professional experience with a mix of work in a high-caliber law firm, government agency, and medical device or pharmaceutical company environment
- Expertise in Food Drug and Cosmetic Act, FDA regulations, and quality management systems
- Strong business and personal ethics and integrity
- Demonstrated experience as a valued regulatory and quality attorney counseling business clients on regulatory issues related to the Federal Food, Drug, and Cosmetic Act
The base salary for this position is estimated to be between $180,000 and $250,000 per year, plus an annual bonus of 25%.
We offer a comprehensive benefits package, including health insurance, a 401k plan, paid time off, and wellness initiatives.
About GetingeGetinge is a global leader in life science solutions, providing hospitals and healthcare institutions with innovative products and services aimed at improving clinical outcomes and optimizing workflows. Our company has a strong commitment to quality and regulatory compliance, and we seek candidates who share this vision.
Why Join Us?We are a dynamic and growing company with a strong focus on innovation and customer satisfaction. As a member of our team, you will have the opportunity to work with a talented group of professionals, develop your skills and expertise, and contribute to the success of our organization. We value diversity, inclusion, and teamwork, and we strive to create a work environment that is both challenging and rewarding.
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