Associate Director, Device Safety Lead

Johnson & Johnson; Toronto; Hybrid; CAD 106,000 - 247,000; Full time

Job summary

A leading healthcare innovation firm is seeking an Associate Director Device Safety Lead in Toronto, Canada. This role focuses on ensuring operational safety for medical devices and requires 8+ years in pharmacovigilance or device safety. The position offers a competitive salary range and extensive benefits including medical and retirement plans.

Benefits

Competitive performance-based compensation

Medical, dental, and vision insurance

Retirement plan participation

Vacation up to 120 hours per year

Qualifications

• 8+ years of experience in pharmacovigilance or device safety with demonstrated medical device experience.
• Ability to lead cross-disciplinary teams to meet safety and compliance objectives.
• Strong written and verbal communication skills.

Responsibilities

• Maintain knowledge of device assets and programs across the portfolio.
• Analyze safety responsibilities to support resource decisions.
• Lead meetings to execute safety-specific deliverables.

Skills

Program assessment

FDA Regulations

Leadership Experience

Operations Management

Research Experience

Strategic Planning

Education

Bachelors degree in Health Sciences or Engineering

Masters degree or higher in Health Sciences or Biomedical Engineering

Tools

Microsoft Office Suite

Job description

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 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 more.

Job Function: Product Safety

Job Sub Function: Drug & Product Safety Operations

Job Category: Professional

Location: Toronto, Ontario, Canada

Job Description:

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.

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

Beerse, Belgium; Lisbon, Portugal; High Wycombe, United Kingdom; Horsham, United States; Raritan, United States; Titusville, United States; Toronto, Canada.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. Focus on the country(s) that align with your preferred location(s):

• Beerse, Belgium or Lisbon, Portugal – Requisition Number: R-026702
• High Wycombe, Bucks, United Kingdom – Requisition Number: R-026706
• USA: Horsham, PA; Titusville, NJ; Raritan, NJ – Requisition Number: R-025535

Purpose

The Device Safety Lead (DSL) is a specialized role ensuring 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 safety processes for in-scope device assets are compliantly executed and maintained across all lifecycle stages.

The DSL will apply knowledge of global device regulations, standards, and guidance (EU MDR/IVDR/MDCG, FDA 21 CFR Part 4, ISO 13485/14971/20916) to support a pharmaceutical-led portfolio.

In a hybrid regulatory and compliance framework, the DSL collaborates with physicians, scientists, and engineers in a highly matrixed environment to execute complex operational tasks and solve challenges professionally.

The DSL serves as a subject matter expert for internal consultations and audits/inspections and participates in special projects to streamline and optimize device processes and metrics.

You will be responsible for

• Maintain a complete knowledge base of in-scope device assets and programs across the portfolio and lifecycle (including integral and non-integral medical devices, in vitro diagnostics, and software-as-a-medical-device).
• Analyze safety responsibilities for each asset to support internal vs external resourcing decisions and work with cross-functional teams to ensure compliant task disposition and timely execution.
• Lead cross-functional meetings to execute safety-specific deliverables for assigned device assets from design through reporting and risk management.
• Create and maintain procedural documents that drive compliant, optimized workflows for device assets within the pharmaceutical portfolio.
• Ensure successful and compliant resolution of competing priorities across multiple stakeholders and programs.
• Maintain performance and risk metrics for device workflows to support strategic decision-making.
• Support 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 drive cross-disciplinary, highly matrixed teams to meet safety and compliance objectives for device assets
• Ability to rapidly assimilate and apply new information for device assets and regulations
• Ability to clearly and concisely summarize complex device safety topics in writing and presentations for diverse audiences
• Strong written and verbal communication skills
• Strong Microsoft Office Suite skills (Word, Excel, PowerPoint)

Salary: The anticipated base pay range for this position is $137,000 - $235,750 USD or $106,000 - $246,100 CAD, depending on location.

The Company maintains competitive performance-based compensation programs. This position is eligible for an annual performance bonus at the Company’s discretion.

Benefits include medical, dental, vision, life insurance, disability, and group legal insurance; participation in the company retirement plan (pension) and savings plan (401(k)). This position may participate in the company long-term incentive program.

Time off and miscellaneous information

• Vacation up to 120 hours per calendar year
• Sick time up to 40 hours per year; in Washington state up to 56 hours per year
• Holiday pay up to 13 days per year
• Work Personal and Family Time up to 40 hours per year

For more information on benefits, please visit the company website. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by law. If you require an accommodation in the interview process, please contact the Employee Health Support Center or AskGS for assistance.

Employment Type: Full-Time

Experience: Director level

Key Skills

Program assessment, FDA Regulations, Manufacturing & Controls, Program Evaluation, budget forecasting, Research Experience, Operations Management, Research & Development, Strategic Planning, Contract Management, Leadership Experience, negotiation

Vacancy: 1