Be an early applicantLess than 25 applicants

Company

Getinge · 3 days ago

Associate General Counsel

Wayne, NJ

Full-time

Remote

Senior Level, Lead/Staff

$180K/yr - $250K/yr

10+ years exp

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Responsibilities

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.

Independently manage projects and take accountability for coordination, communication, and successful execution of such work.

Qualification

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From recognized institutionLicensed to practice lawFDA regulations expertiseFood DrugCosmetic ActQuality management systemsMedical device regulationsClinical trial agreementsRegulatory strategyInfluencing senior managementSoftware as a Medical DeviceMedical device cybersecurityAI in medical devicesProject management

Required

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, FDA promotional and other regulatory requirements from FDA, and various state regulators

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

Knowledge of FDA digital health focus areas such as Software as a Medical Device, medical device cybersecurity, AI / machine learning in medical devices, and device software functionality

Strong understanding of quality management systems and standards

Flexible and resilient professional with the demonstrated ability to influence senior management and build consensus across the business and functions

The successful candidate will embody Getinge’s core values of being a team player, game changer, and forward thinker

Demonstrated ability to prioritize work and timely complete assignments with limited supervision in a team and cross-functional, matrixed environment

Excellent written and oral communication skills

Travel of approximately 20%, may include international travel