Manager Global Post Market Safety - Johnson and Johnson

Johnson & Johnson is currently recruiting for a Manager Global Post Market Safety! This position will be located in Irvine, CA.

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/ .

Position Summary:

Manages global complaint handling and adverse event reporting activities related to medical or other devices manufactured and/or distributed. Manages evaluation of incoming product complaints, reportability assessment decisions per Health Canada Drug and Medical Device regulations including global regulations. Adheres to environmental policy, procedures, and supports department environmental objectives.

Key Responsibilities:

Develops improvements to existing complaint processing system. Creates systems for compiling metrics and trending of customer complaints and adverse events. Interfaces with local government regulatory, quality control systems and external auditing bodies. Mentors and facilitates successful team behavior in the development of the customer complaint department. Manages staff to resolve complaints for all products and ensures all regulatory requirements are maintained. Ensures that incoming complaints are reviewed for reportability and that follow up is provided to external customer as required. Provides direction and leadership for the investigation and resolution of all customer complaints in a timely manner.

Main areas of responsibility:

Manages and coordinates activities of employees engaged in the complaint handling and adverse event reporting process. In addition, may be required at times to complete these tasks. May manage both Non Exempt and Exempt associates including Healthcare Professionals.

In addition to managing complaint handling, provide Quality Assurance leadership with product quality data, statistical analysis and complaint trending to drive product improvements and Corrective and Preventive Actions. In conjunction with Corporate QA, assists in field actions (including product recalls) as required.

Prepare or assist department leadership with monthly trending reports, annual post-market surveillance reports and other monthly and quarterly reports. Lead or participate in various process improvement projects.

Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising and managing performance; addressing complaints and resolving problems.

Evaluate complaints and investigation conclusions for medical impact with review and consideration of product risk management information. Establish medical impact classifications for product complaints and support alignment with the product risk management process. Education:

A minimum of a Bachelor's or equivalent University degree is required.

Required:

• A minimum of 6-8 years relevant work experience.

• Knowledge and understanding of FDA, EU, EUMDR, Canada Medical Device Regulations and applicable worldwide regulations, standards and guidelines pertaining to safety of drugs and devices (includes emerging new regulations that may be country specific)

• Understands relevant post market surveillance requirements. Be able to assess impact to post market surveillance based on emerging global regulations.

• Strong analytical, organizational, and problem-solving abilities.

• Experience with complaint handling for medical products is a benefit.

• Excellent verbal and written communication skills.

• Ability to work well in a team environment.

Other:

• This position may require up to 10% domestic travel.

The anticipated base pay range for this position is $99,000-$170,200.

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)).
• 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 of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.