Manager, Device Safety Associate
Manager, Device Safety Associate
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Job Description
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions 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 at
Job Function:
Product SafetyJob Sub Function:
Drug & Product Safety OperationsJob Category:
ProfessionalAll Job Posting Locations:
Toronto Ontario CanadaJob 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.
Learn more at are searching for the best talent for a Manager Device Safety Associate J&J Innovative Medicine to be located in:Beerse Antwerp / Belgium
High Wycombe Bucks / United Kingdom
Horsham PA / United States
Lisbon / Portugal
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 Portugal - Requisition Number: R-026734
High Wycombe Bucks / United Kingdom - Requisition Number: R-026735
USA Horsham PA Raritan NJ or Titusville NJ - Requisition Number: R-025531
Purpose:
The Device Safety Associate (DSA) 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 DSA 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 DSA 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 DSA 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
Required:
- minimum of 4 years of combined experience and post-baccalaureate education 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 $115000 - $197800 USD
The anticipated base pay range for this position is $91000 - $210450 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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Companys 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:
- & 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 () or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
$91000.00 - $210450CADAdditional Description for Pay Transparency:
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 () or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
$91000.00 - $210450CADAdditional Description for Pay Transparency:
Required Experience:
Manager
Employment Type
Full-Time
