Quality Attorney

About the Job

The Associate General Counsel, Regulatory & Quality, will support a wide range of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide.

Key Responsibilities

1. Regulatory Advice: Provide solutions-oriented and strategic legal advice regarding Getinge's interactions with the FDA and other regulatory authorities.
2. Quality System Regulations: Ensure compliance with the FDA's Quality System Regulation, Good Manufacturing Practices, and other regulatory requirements.
3. Field Actions: Support field actions, including recalls, product withdrawals, and market corrections, by providing counsel and strategic guidance to regulatory affairs and business leadership.
4. Policy Development: Develop and implement policies, procedures, product manuals, legal guidance documents, and training materials, as well as training of personnel on FDA regulatory and quality matters.

Qualifications

• JD: From a nationally recognized institution.
• Licensure: Licensed in good standing to practice law in at least one state and one federal jurisdiction within the United States.
• Expertise: Expertise in Food Drug and Cosmetic Act, FDA regulations, FDA promotional and other regulatory requirements from FDA, and various state regulators.