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Johnson & Johnson Services, Inc.

Supervisor Regulatory Reporting

Johnson & Johnson Services, Inc. - Irvine, CA

Supervisor Regulatory Reporting

in

Irvine

California

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

Timeliness Metrics.

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

complaints.

Investigate and develop solutions to procedures and process

related issues.

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

needed.

Performs other duties assigned as needed.

Qualifications

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

is required.

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

is preferred.

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

preferred.

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

international travel.

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

law.

Primary Location

United States-California-Irwindale

Other Locations

North America-United States-California-Irvine

Organization

Biosense Webster Inc. (6010)

Job Function

Quality Assurance

Requisition ID

3456171026

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Supervisor Regulatory Reporting Johnson & Johnson Services, Inc. - Irvine, CA, United States

   

Location: Irvine, CA

Company Profile:
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.