New Jersey Staffing
Associate Director, Device Safety Lead, J&J Innovative Medicine
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. 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 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 Analyzing safety responsibilities for each device asset to support internal vs. external resourcing decisions Leading cross-functional meetings to execute safety-specific deliverables for assigned device assets 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. 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 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.
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. 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 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 Analyzing safety responsibilities for each device asset to support internal vs. external resourcing decisions Leading cross-functional meetings to execute safety-specific deliverables for assigned device assets 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. 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 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.