Device Safety Officer

Biopharma Careers; Raritan (NJ); On-site; USD 199,000 - 344,000; Full time

Benefits offered by this job

401(k) plan

Long-term incentive program

Vacation 120 hours/year

Sick time 40 hours/year

Parental Leave 480 hours

Job summary

Johnson & Johnson is seeking a Device Safety Officer (DSO) to lead medical device safety across design, development and post-market lifecycles. You will act as the accountable medical safety expert for cross-functional teams and ensure compliance with global device regulations.

The role requires an MD/DO-type credential with post-graduate training and clinical experience, a medical license, and strong risk-management capabilities.

Qualifications

• MD/MBBS/DO or equivalent with at least 3 years of postgraduate training and 2 years of clinical practice.
• Active medical license and board certification in a relevant discipline strongly preferred.
• Ability to drive cross-disciplinary, highly matrixed teams to meet safety and compliance objectives.
• Experience applying risk management to medical devices.
• Ability to summarize complex device safety topics in writing and presentations.
• Strong written and verbal communication skills; proficient in Word, Excel, PowerPoint.

Responsibilities

• Evidence-based decision making for the severity of harms as a result of device-associated hazardous situations and probabilities.
• Documenting, explaining, and defending device risk assessment decisions and updating PRM deliverables.
• Representing Global Medical Safety at RMTs and quality event meetings.
• Review and sign off on device Product Risk Assessments and other PRM deliverables.
• Leading standardization initiatives, including the development and maintenance of a global harms list.
• Maintaining a comprehensive knowledge base of device assets and programs across the portfolio.

Skills

Clinical Operations

Compliance Management

Leadership

Risk Management

Safety Investigations

Medical Device Regulation

Communication Skills

Education

MD/MBBS/DO or equivalent

Board Certification preferred

Tools

Microsoft Office

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

Job Function

Product Safety

Job Sub Function

Product Safety Risk Management MD

Job Category

Scientific/Technology

All Job Posting Locations

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description

Purpose:

The Device Safety Officer (DSO) is a specialized role that ensures medical safety excellence at the intersection of pharmaceuticals and medical devices. Utilizing their medical / surgical training and deep domain expertise in device risk management, the DSO is the single point of accountability for the medical assessment of device asset risk throughout the design, development, and post-market lifecycle for assigned programs and products.

As a member of the J&J Innovative Medicine Safety Management Team (SMT) for assigned programs and products, the DSO represents Global Medical Safety as the primary point of accountability for cross-functional device Risk Management Teams (RMT).

The DSO is expected to utilize and remain current in their knowledge of global device regulations, standards, and guidance to support this mission within a pharmaceutical-led portfolio, including but not limited to EU MDR/IVDR/MDCG, FDA 21 CFR Part 4, and ISO 14155/14971/20916.

In addition, the DSO will serve as a subject matter expert in their role for internal consultations, audits/inspections, and other proceedings, and will participate in special projects and initiatives to streamline and optimize device processes and meet key performance metrics.

You will be responsible for:

• Evidence-based decision making for the severity of harms as a result of device-associated hazardous situations and associated probabilities of harm.
• Documenting, explaining, and defending device risk assessment decisions made, and updating Product Risk Management (PRM) deliverables based on new evidence and inputs from cross-functional peers and stakeholders.
• Representing Global Medical Safety at RMTs and quality event meetings convened for device assets.
• Review and sign off on device Product Risk Assessments (PRA) and other PRM deliverables requiring medical input.
• Leading standardization initiatives, including the development and maintenance of a global harms list.
• Ensuring a complete and comprehensive knowledge base of in-scope device assets and programs across the portfolio and product lifecycle, including but not limited to integral and non-integral medical devices, in vitro diagnostics, and software-as-a-medical device.
• Ensuring successful and compliant resolution of competing priorities and objectives across multiple stakeholders and programs.
• Meeting performance and risk metrics for device workflows that support strategic decision-making.
• Supporting special projects and initiatives as needed.

Qualifications:

• Physician / Surgeon (MD, MBBS, DO, or equivalent), with at least 3 years of postgraduate training and 2 years of clinical practice experience is required.
• At least 2 years of experience in the application of risk management to medical devices is required.
• An active medical license and board certification in a relevant discipline is strongly preferred.
• Ability to effectively drive cross-disciplinary, highly matrixed teams to meet safety and compliance objectives for device assets is required.
• Ability to rapidly assimilate and apply new information for device assets and regulations is required.
• Demonstrated ability to leverage AI-enabled tools and technologies to improve decision-making, streamline work processes, and enhance business outcomes.
• Ability to clearly and concisely summarize complex device safety topics in writing and in presentations for audiences of diverse professional backgrounds is required.
• Strong written and verbal communication skills are required.
• Strong Microsoft Office Suite skills (Word, Excel, PowerPoint) are required.

Required Skills:

Preferred Skills: Clinical Operations, Compliance Management, Compliance Risk, Consulting, Design Mindset, Developing Others, Leadership, Medicines and Device Development and Regulation, Operational Excellence, Quality Control (QC), Research Ethics, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Succession Planning, Surveillance

Salary

The anticipated base pay range for this position is : $199,000.00 - $343,850.00

Additional Description for Pay Transparency: The anticipated pay range for this role is $199,000 - $343,275.

Benefits

• Subject to the terms of their respective plans, employees are 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.
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits