Medical Safety Officer- Heart Recovery

Medical Safety Officer

• Heart Recovery 4.2 4.2 out of 5 stars Danvers, MA Hybrid work $199,000
• $343,275 a year
• Full-time Johnson & Johnson 8,348 reviews $199,000
• $343,275 a year
• Full-time 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 jnj.com 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 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.

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 J&J MedTech 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 J&J MedTech's patient-centered innovation process. The MSO will have primary responsibility for one or more companies within

J&J MedTech 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 The anticipated base pay range for this position is : The anticipated base pay range for this position is: $199,000

• 343,275 Additional Description for

Pay Transparency:

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. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation
• up to 120 hours per calendar year Sick time
• up to 40 hours per calendar year; for employees who reside in the State of Washington
• up to 56 hours per calendar year Holiday pay, including Floating Holidays
• up to 13 days per calendar year of Work, Personal and Family Time
• up to 40 hours per calendar year Additional information can be found through the link below.

https:

//www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 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. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.