Associate Director, Regulatory Affairs - Ethicon, Inc
Company: Johnson & Johnson
Location: Philadelphia
Posted on: November 20, 2023
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Job Description:
Job Description - Associate Director, Regulatory Affairs -
Ethicon, Inc. (2306151725W) Associate Director, Regulatory Affairs
- Ethicon, Inc. - 2306151725W Description Ethicon, Inc., a member
of Johnson & Johnson Family of Companies, is currently recruiting
for an Associate Director, Regulatory Affairs.The preferred
location for this role is Raritan, NJ however remote options in the
Eastern United States or Western Europe will be considered on a
case-by-case basis. Caring for the world, one person at a time has
inspired and united the people of Johnson & Johnson for over 130
years. We embrace research and science -- bringing innovative
ideas, products, and services to advance the health and well-being
of people. With $82.5 billion in 2020 sales, Johnson & Johnson is
the world's most comprehensive and broadly-based manufacturer of
health care products, as well as a provider of related services,
for the consumer, pharmaceutical, and medical devices markets.
There are more than 260 Johnson & Johnson operating companies
employing over 135,000 people, who help deliver products that touch
the lives of over a billion people every day throughout the world.
If you have the talent and desire to touch the world, Johnson &
Johnson has the career opportunities to help make it happen.
Thriving on a diverse company culture, celebrating the uniqueness
of our employees, and committed to inclusion. Johnson & Johnson
Medical Devices is focused on shaping the future of surgery with
multi-specialty, end-to-end solutions in orthopedics, endoluminal
intervention and general surgery. -Ethicon, Inc., part of Johnson &
Johnson Medical Devices Companies, has made significant
contributions to surgery for more than 100 years from creating the
first sutures, to revolutionizing surgery with minimally invasive
procedures. Our continuing dedication to Shape the Future of
Surgery is built on our commitment to help address the world's most
pressing health care issues and improve and save more lives.
Through Ethicon's surgical technologies and solutions including
sutures, staplers, energy devices, trocars and hemostats and our
commitment to treat serious medical conditions like obesity
worldwide, we deliver innovation to make a life-changing impact.
For more information, visit - www.ethicon.com . OVERALL
RESPONSIBILITIES: The Associate Director, Regulatory Affairs for
Ethicon's Biosurgery business unit will be responsible for
partnering with R&D and Global Strategic Marketing platform
leaders as well as other cross-functional team members/leaders to
develop and execute global regulatory strategies to drive pipeline
development and global launch excellence.Products supported are
considered significant-risk medical devices worldwide to address a
range of surgical challenges related to sealing and bleeding (e.g.,
Class II and Class III devices in the US).This role may also
support combination product strategy (i.e., biologics/medical
device) in a limited capacity.Primary responsibilities will include
the development and execution of regulatory strategies to obtain
market access for new/modified products and lifecycle management
activities required to maintain existing products globally.The
Associate Director is also responsible for evaluating the impact of
current and emerging standards and regulations and determining the
most effective and efficient strategies for obtaining or
maintaining product clearances/approvals/registrations in key
markets. POSITION DUTIES & RESPONSIBILITIES: - Act as a strategic
partner with colleagues in R&D, Preclinical Research, Clinical
Development, Global Strategic Marketing, Supply Chain, and Health
Economics Market Access teams to develop and execute global
regulatory strategies for new and existing products to assure
on-time regulatory approval/clearance and post-marketing activities
with a focus on strategic markets. - Leverage a deep scientific and
technical understanding of products under the scope of
responsibility to provide strategic guidance and support for
product development and life-cycle management of products. -
Develop and submit US and EU regulatory filings such as
Pre-submissions, IDEs, PMAs, 510ks, and Design Dossier/Technical
Files. Partner with regional leaders on regulatory strategy and
submissions to successfully obtain marketing approvals for all
other markets. - Lead Health Authority meetings for key markets and
interact with Health Authorities regarding product regulatory
filings. - Partner with regional leaders and the Regulatory Affairs
Policy Intelligence team to monitor the regulatory environment
globally and assess and communicate the impact of current and
emerging regulations on the company's portfolio of products, define
the future vision, and drive innovative thinking. - Integrate large
amounts of changing, complex, and/or ambiguous information for
effective decision-making and clearly communicate complex issues
and solutions to stakeholders to achieve strategic and/or project
goals. - Review product design, labeling, and manufacturing changes
to existing products to assess the impact to safety and efficacy. -
Collaborate with Legal and Quality partners regarding product
safety and quality issues. Contribute to risk management plans and
failure mode analysis during product development and safety signal
detection and post- market surveillance post-launch. - Apply
Regulatory knowledge of competitor products, strategies, and market
segmentation to help identify opportunities and potential
Regulatory challenges. - Manage, oversee and balance resource
allocation across critical projects. - Provide key input for
product claims and evidence support, and review and approve
Advertising and Promotional materials in accordance with local
regulations. - Lead, inspire, and coach RA staff members, directly
or indirectly. - Influence and collaborate to bring about process
and technical improvements within the organization. - Represent the
company and influence regulations and health authority guidance
through industry trade association(s) in partnership with the
Policy Intelligence team. - Ensure that company policies,
procedures and practices are in compliance with appropriate
regulatory requirements. The base pay range for this position is
$140,000 to $225,000 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. The compensation
and benefits information set forth in this posting applies to
candidates hired in the United States. Candidates hired outside the
United States will be eligible for compensation and benefits in
accordance with their local market. Qualifications EDUCATION &
EXPERIENCE REQUIREMENTS:
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Keywords: Johnson & Johnson, Philadelphia , Associate Director, Regulatory Affairs - Ethicon, Inc, Executive , Philadelphia, Pennsylvania
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