What are the responsibilities and job description for the FDA Compliance Specialist position at Getinge?
About the Position
We are looking for a highly experienced Associate General Counsel, Regulatory & Quality, to join our team at Getinge.
Main Responsibilities
- Regulatory Support: Provide legal guidance to business teams on FDA regulations relating to medical device product submissions, including 510(k)s and PMAs, manufacturing and post-market requirements, and labeling compliance.
- Regulatory Strategy: Collaborate with regulatory and quality affairs teams to develop and implement regulatory strategies for Getinge's medical devices and other regulated products.
- Compliance: Ensure compliance with FDA regulations, guidance documents, and industry standards, including quality system regulations, good manufacturing practices, and promotional requirements.
- Audit and Inspection Support: Prepare for and respond to FDA audits and inspections, as well as enforcement actions such as warning letters and 483s.
Required Qualifications
- Education: JD from a nationally recognized institution.
- Experience: Minimum 10 years of relevant professional experience in a high-caliber law firm, government agency, and medical device or pharmaceutical company environment.
- Skills: Expertise in Food Drug and Cosmetic Act, FDA regulations, and various state regulators; strong business and personal ethics and integrity; ability to influence senior management and build consensus across the business and functions.
