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**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, Interventional Cardiology to be located in Danvers, MA.
The MSO role is to provide medical safety stewardship for Medical Device (MD) products. Although a medically independent voice is key, collaboration in assessing potential safety signals is expected. The MSO is an active member of diverse cross functional teams, and a close partner with the quality leader and statistical colleagues, in assessing any potential safety signal for MD products including J&J Vision products as assigned by Senior Safety Officer.
The MSO will execute on the Medical Safety Organization's strategy, by implementing programs and leading in the strategic priority areas as defined by the Chief Medical Officer.
The MSO will build clear and strong relationships between Medical Affairs, R&D, Quality, Regulatory, Clinical, Epidemiology to allow for proactive and flexible risk management system. The MSO is knowledgeable in risk management and serves as a subject matter expert in the therapeutic area and patient risk management throughout the product lifecycle, from new product development, to launch and commercial life.
The MSO plays a pivotal role in evaluating customer/user risk and in assessing the actual or potential impact of product performance issues on patient safety. The reactive elements of the role (addressing Quality/performance issues) are balanced with the need for a proactive approach in continually assessing all available information/data sources and advising on any mitigating activities which should be taken to minimize potential risk to patients. Further, the MSO must be a trusted partner in the innovation process, engaging with R&D, Medical Affairs and quality engineering to drive MD and J&J Vision's patient-centered innovation process.
The MSO will have primary responsibility for one or more companies within MedTtech and J&J Vision.
+ 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, Data Gathering Analysis, Developing Others, Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Mentorship, Presentation Design, Quality Control (QC), Research Ethics, Risk Compliance, Risk Management, Risk Management Framework, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Technical Writing