Medical Safety Officer- Heart Recovery

Overview At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Details Job Function: Product Safety Job Sub Function: Product Safety Risk Management MD Job Category: People Leader All Job Posting Locations: Danvers, Massachusetts, United States of America Job Description: Johnson & Johnson is currently seeking a Medical Safety Officer (MSO)- Heart Recovery, Cardiac Surgery/Interventional Cardiology to be located in Danvers, MA. Responsibilities Lead Safety Management: Chair the Safety Management Team (SMT) and oversee safety aspects of devices, including benefit/risk profiles throughout the product lifecycle. Risk Management: Conduct risk assessments, review clinical evaluation reports, and develop safety surveillance plans. Provide input on risk management plans and post-market surveillance. Product & Clinical Oversight: Represent medical safety in product reviews, approve safety content for labeling, and oversee clinical study safety deliverables (protocols, safety plans, reports). Safety Data Analysis: Interpret post-marketing safety data, complaints, adverse events, and literature reports. Advise on mitigations and safety communications. Stakeholder Collaboration: Work closely with Medical Affairs, R&D, Quality, Regulatory, and other cross-functional teams to ensure proactive risk management and patient safety. External Monitoring: Monitor regulatory, market, and scientific trends; interface with customers and health authorities as needed. Regulatory & Audit Support: Act as a subject matter expert in audits, regulatory interactions, and due diligence for acquisitions. Required Experience & Education Degree: Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent (e.g., MBChB). Experience: Minimum 3 years clinical or research experience, with relevant background in interventional cardiology or heart failure. Technical Knowledge: Familiarity with ISO 14971, basic statistics, epidemiology, and clinical research concepts. Skills: Strong communication, stakeholder influence, and proficiency with Microsoft Office. Preferred Qualifications Experience with J&J Heart Recovery/Abiomed Impella Pumps. Background in risk evaluation, medical device/pharma industry, and clinical research. Knowledge of local/international medical device regulations and advanced statistical methods. Experience interfacing with senior leadership in global healthcare. Required Skills Preferred Skills: Clinical Operations, Compliance Management, Compliance Risk, Data Gathering and Analysis, Developing Others, Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Mentorship, Presentation Design, Quality Control (QC), Research Ethics, Risk Management, Risk Management Framework, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Technical Writing Compensation & Benefits The anticipated base pay range for this position is: $199,000-$343,275 . The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation\'s performance over a calendar/performance year. Bonuses are awarded at the Company\'s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. The text also notes retirement plans, time off benefits, and other details available via the linked careers site. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource. #J-18808-Ljbffr Johnson & Johnson