Manager, Regulatory Affairs - Biosense Webster, Inc.
Company: Disability Solutions
Location: Irvine
Posted on: May 6, 2024
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Job Description:
Biosense Webster, part of the Johnson & Johnson MedTech family,
is currently recruiting for a Manager, Regulatory Affairs . This
role will work a Flex/Hybrid schedule and must be located within a
commutable distance of Irvine, CA . About Johnson & Johnson 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 DUTIES &
RESPONSIBILITIES --- Ensure compliance with global regulations and
regulating agencies. Interpret the intent of regulations and
policies and provide such information to project teams and
management. --- Instill and drive a regulatory culture. Establish
and support policies and standards for new products. --- Manages
the generation of documentation to be submitted to worldwide
governmental regulatory agencies in order to secure approvals to
market products manufactured and/or distributed by BWI and/or
J&J affiliates. --- Develop IDE/510K/ and PMA submissions for
class II and III medical devices for commercialization in the USA.
--- Develop Technical File/ Design Dossier submissions for class II
and III medical devices for CE Mark Approval. --- Conduct
submission negotiations with the FDA as needed, including
pre-submission identification of requirements and strategy and post
submission negotiations to ensure timely approval. --- Maintain
proficiency on regulatory requirements; develop and maintain
rapport with FDA reviewers, project team members. --- Provide
continuing regulatory education and dissemination of regulatory
information to the product development, marketing, and clinical
groups. --- Carries out supervisory responsibilities in accordance
with the organization's policies and applicable laws.
Responsibilities include interviewing, hiring, and training
employees; planning, assigning, and directing work; appraising
performance; rewarding and disciplining employees; addressing
complaints and resolving problems. --- Responsible for ensuring
that 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. --- Works with others as
a team player to successfully achieve strategy. Must be cooperative
and work well with all functional groups. --- Directly or through
subordinate staff, generates documentation to worldwide
governmental regulatory agencies in order to secure approvals to
market products manufactured and/or distributed by BWI and/or
J&J affiliates. --- Responsible for providing performance
feedback to direct reports as well as coaching and assistance in
their development. --- Assist in the identification and management
of departmental project and personnel issues. Responsible for
communicating business related issues or opportunities to next
management level --- Responsible for ensuring personal and Company
compliance with all Federal, State local, and Company regulations,
policies, and procedure --- Perform Copy Review for internal and
external facing documentation to ensure compliance with applicable
Federal, State, local and Company regulations, policies, and
procedures. The base pay range for this position is $115,000 to
$180,000 based on experience . The Company maintains highly
competitive, performance-based compensation programs. Under current
guidelines, this position is eligible for an annual performance
bonus. 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 may be eligible to
participate in Company employee benefit programs such as health
insurance, savings plan, pension plan, disability plan, vacation
pay, sick time, holiday pay, and work, personal and family time off
in accordance with the terms of the applicable plans. Additional
information can be found through the link below.
Keywords: Disability Solutions, Glendora , Manager, Regulatory Affairs - Biosense Webster, Inc., Executive , Irvine, California
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