Supervisor Regulatory ReportingJohnson & Johnson Services, Inc. - Irvine, CA
Supervisor Regulatory Reporting
Johnson & Johnson’s Cardiovascular&
Specialty Solutions (CSS) Group within Medical Devices is recruiting for
Supervisor Regulatory Reporting located in Irvine, CA or Irwindale, CA.
The CSS Group consists of six diverse businesses including
Advanced Sterilization Products (ASP), Acclarent, Biosense Webster (BWI),
Mentor, Neurovascular and Sterilmed. The CSS Group serves a diverse base of
customers in Ear, Nose and Throat (ENT), Infection Prevention,
Electrophysiology, Surgical and Non-Surgical Aesthetics, Neurovascular and
Reprocessing. The CSS Group is committed to delivering innovative products,
solutions and programs to address unmet customer and patient needs around the
world. Our customers and the patients they treat are our first priority and
these values are reflected in Our Credo, which guides our daily decisions and
actions. Our relentless commitment to Quality and the principles that define us
in Our Credo have helped us achieve significant milestones and continues to
help us deliver significant growth year after year.
As the Supervisor Regulatory Reporting you will be responsible for
maintaining the quality processes associated with regulatory reporting and its
procedures and controls to ensure that all MDR reportable complaints are
processed and submitted in accordance with established company procedures and
worldwide regulations and standards. This individual will oversee the
review of reportable and potentially reportable complaints from incoming calls,
faxes, and emails from all areas of the world. This individual will also ensure
adequate information is received to warrant timely reporting, investigation, and
closure of reportable complaints, including sound regulatory reporting
decisions/justifications for worldwide reporting. The individual applies
standard practices and procedures, adjusts and correlates data, recognizes
discrepancies in results, and follows operations through a series of related
detailed steps and processes.
You the Supervisory Regulatory Reporting will:
Be responsible for the overall regulatory reporting process
(timely submissions, closure, health authority requests etc.)
Develop and coordinate workload of MDR Complaint Specialists.
Be responsible for CSS and J&J MDR Timeliness and Closure
Plan, develop, coordinate and/or support departmental projects
from different levels of complexity.
Effectively communicate with worldwide complaint groups, as well
as other internal departments such as Marketing, R&D, Customer Service and
Technical Services as needed.
Guarantee controls are in place to ensure regulatory reports are
submitted on time.
Possess a thorough understanding of the complaint database and
regulatory reporting process.
Profoundly understands principles, theories, concepts and
techniques related to complaint review and regulatory reporting of customer
Investigate and develop solutions to procedures and process
Support of audits, both internal and external in nature.
Ensure compliance with the company's Quality System policies and
procedures and applicable external requirements and standards, including FDA,
ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson &
Johnson Environmental, Health & Safety Practices, and other applicable
standards as pertains to medical devices.
Be responsible for ensuring personal and Company compliance with
all Federal, State, local and company regulations, policies and procedures for
Health, Safety and Environmental compliance.
Escalate critical issues for proper disposition as necessary.
In a supervisory capacity, develop, mentor, plan and coordinate workload
for MDR team.
In a supervisory capacity, plan, develop, coordinate, and direct
projects with varying levels of complexity.
Be responsible for conducting Performance Reviews and set Goals
& Objectives for MDR team.
Be responsible for ensuring subordinates follow all Company
guidelines related to Health, Safety and Environmental practices and that all
resources needed to do so are available and in good condition.
Respond to FDA and/or other worldwide health authority requests as
Performs other duties assigned as needed.
A minimum of a Bachelor's Degree and
a minimum of 6 years relevant business experience is required.
A Bachelor's Degree in a health
science field, Registered Nurse (RN) Degree/License, RPh, Phar.D. or
equivalent is preferred.
Knowledge of medical terminology
A minimum of 2 years of people
management experience is required.
Strong understanding of external
requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other
worldwide regulatory agencies is required.
Experience in scientific research
Regulatory Affairs/ Quality
Assurance and/or complaint handling experience in the Pharmaceutical or Medical
Device industry is preferred.
Knowledge of regulatory reporting
requirements is preferred.
Experience with health hazard
evaluations is preferred.
Experience interacting with the
FDA is preferred.
Risk Management experience is
Excellent communication and
analytical skills are required.
Knowledge of Microsoft Office
(Word, Excel, PowerPoint, and Outlook) is required.
The ability to collaborate in a
cross-functional team environment is required.
This position will be located in
Irvine, CA or Irwindale, CA and may require up to 15% domestic and or
Johnson & Johnson Family of Companies are equal
opportunity employers, and all qualified applicants will receive consideration
for employment without regard to race, color, religion, sex, sexual
orientation, gender identity, genetic information, national origin, protected
veteran status, disability status, or any other characteristic protected by
North America-United States-California-Irvine
Biosense Webster Inc. (6010)
J&J Family of Companies
J&J Family of Companies Jobs
9 days 16 hours ago
applySupervisor Regulatory Reporting Johnson & Johnson Services, Inc. - Irvine, CA, United States
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. Johnson & Johnson was founded more than 120 years ago. Since then, we’ve brought the world new ideas and products that have transformed human health and well-being.
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