Associate Director, Device Safety Lead

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 https://www.jnj.com

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About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for an Associate Director, Device Safety Lead, J&J Innovative Medicine to be located in:

Beerse, Antwerp / Belgium

Lisbon / Portugal

High Wycombe, Bucks / United Kingdom

Horsham, PA / United States

Raritan, NJ / United States

Titusville, NJ / United States

Toronto, ON / Canada

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Beerse, Belgium or Lisbon, Portual - Requisition Number: R-026702

USA, Horsham, PA, Titusville, NJ, or Raritan, NJ - Requisition Number: R-025535

Toronto, ON / Canada - Requisition Number: R-026708

Purpose:

The Device Safety Lead (DSL) is a specialized role that ensures operational safety excellence at the intersection of pharmaceuticals and medical devices. As a member of the Global Medical Safety Operations group in J&J Innovative Medicine, they are responsible for ensuring that safety processes for in-scope device assets are compliantly executed and maintained across all lifecycle stages.

The DSL 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 13485/14971/20916.

Within this hybrid regulatory and compliance framework, the DSL is expected to bring together physicians, scientists, and engineers of diverse backgrounds in a highly matrixed environment to execute complex operational tasks and solve challenges in a collaborative and professional manner.

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

You will be responsible for:

• 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.
• analyzing safety responsibilities for each device asset to support internal vs. external resourcing decisions, and work with cross-functional teams to ensure compliant task disposition and execution in a timely manner.
• leading cross-functional meetings to execute safety-specific deliverables for assigned device assets, beginning at design time and throughout reporting and risk management activities.
• creating and maintaining procedural documents that drive compliant, optimized workflows for device assets within the pharmaceuticals portfolio.
• ensuring successful and compliant resolution of competing priorities and objectives across multiple stakeholders and programs.
• maintaining performance and risk metrics for device workflows that support strategic decision-making.
• supporting special projects and initiatives as needed.

Education:

• Bachelors degree in a Health Sciences or Engineering discipline is required
• Masters degree or higher in a Health Sciences or Biomedical Engineering discipline is preferred

Required:

• A minimum of 8 years of experience in pharmacovigilance, device safety, or biomedical/systems engineering (with demonstrated medical device experience) is required
• 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
• 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

The anticipated base pay range for this position is $137,000 - $235,750 USD.

The anticipated base pay range for this position is $106,000 - $246,100 CAD.

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
• Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.

For additional general information on Company benefits, please go to:

• https://www.careers.jnj.com/employee-benefits

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 ([email protected]) or contact AskGS to be directed to your accommodation resource.