Associate General Counsel, Regulatory & Quality (NJ/NY/Washington DC/Remote US)
Date: Aug 21, 2024
Location: Wayne, NJ, US; New York City, NY, US; Richmond, VA, US; MD, US
Remote Work: Yes
Salary Range: $180,000-$250,000 + bonus targeted at 25%
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 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.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.Support field actions, including recalls, product withdrawals, and market corrections.Provide legal support in the development and implementation of policies, procedures, product manuals, legal guidance documents, and training materials.Proactively monitor legislation, regulations, case law, and government oversight activities relating to FDA regulatory and quality issues.Draft, review, and negotiate agreements for the quality, regulatory, and medical affairs departments.Collaborate with legal colleagues and cross-functional stakeholder teams.Independently manage projects and take accountability for coordination, communication, and successful execution of such work.Minimum Qualifications
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.Expertise in Food Drug and Cosmetic Act, FDA regulations, and various state regulators.Strong business and personal ethics and integrity.Demonstrated experience as a valued regulatory and quality attorney.Knowledge of FDA digital health focus areas.Strong understanding of quality management systems and standards.Excellent written and oral communication skills.Travel of approximately 20%, may include international travel.The base salary for this position is a minimum of $180,000 and a maximum of $250,000, plus an annual bonus of 25%.
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.
Benefits at Getinge:
- Health, Dental, and Vision insurance benefits.
- 401k plan with company match.
- Paid Time Off.
- Wellness initiative & Health Assistance Resources.
- Life Insurance.
- Short and Long Term Disability Benefits.
- Health and Dependent Care Flexible Spending Accounts.
- Parental and Caregiver Leave.
- Tuition Reimbursement.
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
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