Associate General Counsel, Regulatory & Quality (NJ/NY/ Washington DC/ Remote US)

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Job Overview

 

The Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, manufacturing activities, field corrective actions, and labeling requirements.

 

Job Responsibilities and Essential Duties

• Provide legal guidance to business and functional teams (e.g. executive management, regulatory and quality affairs, medical and clinical affairs, R&D) regarding FDA regulations relating to medical device product submissions; regulatory strategy and pre-market applications, including 510(k)s and PMAs; and, manufacturing and post-market requirements, including field corrective actions, CAPAs, and complaint handling.
• Provide solutions-oriented and strategic legal advice regarding Getinge’s interactions with the FDA and other regulatory authorities. Provide authoritative legal interpretations of FDA regulations, guidance documents, and industry standards.
• Interact with the regulatory agencies in partnership with regulatory and quality affairs regarding regulatory strategy, and marketing and product registration requirements for Getinge’s medical devices and other regulated products.
• Participate in all aspects of Getinge’s remediation related to its Consent Decree with the Department of Justice  regarding FDA quality system violations.
• Review and provide support and approval for 510(k) premarket notifications, Premarket Approval applications, Investigational Device Exemptions, clinical study reports, and other regulatory submissions to external agencies and investigators.
• Review and ensure compliance with the FDA’s Quality System Regulation, Good Manufacturing Practices, and other regulatory requirements. Provide legal guidance in preparation for FDA audits and inspections, and in responding to FDA 483s, warning letters, and other enforcement actions.
• Support field actions, including recalls, product withdrawals, and market corrections, by providing counsel and strategic guidance to regulatory affairs and business leadership to ensure appropriate risk mitigation. Serve as a member of the company’s field action council.
• Provide legal support in the development and implementation of policies, procedures, product manuals, legal guidance documents, and training materials, as well as training of personnel on FDA regulatory and quality matters.
• Proactively monitor legislation, regulations, case law, and government oversight activities relating to FDA regulatory and quality issues and provide proactive, strategic advice.
• Draft, review, and negotiate agreements for the quality, regulatory, and medical affairs departments, including but not limited to quality agreements, clinical trial agreements, services agreements, material transfer agreements, research agreements, investigator-initiated trials, sponsored research, collaboration / partnering / joint research and development, contract research organization, and other vendor arrangements.
• Collaborate with legal colleagues and cross-functional stakeholder teams to ensure appropriate expertise is applied to regulatory strategy, product development, and product approvals; advertising and promotion; post-approval compliance; FDA enforcement actions and litigation; M&A due diligence and integrations; and transactional support.
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