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Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Director,
Regulatory Affairs in Milpitas, CA or Santa Ana, CA with a possibility of
remote work. JJSV designs, manufactures, and distributes products for the
surgical treatment of anterior segment ophthalmic disorders, most notably
cataract removal.Caring for the world, one person at a time has inspired and united the
people of Johnson & Johnson for over 125 years. 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.The Johnson & Johnson Surgical Vision goal is improving sight
throughout a patient’s lifetime. J&J Surgical Vision is well positioned to
address a full range of vision health needs for global markets: The No. 2
global provider of CATARACT products and a leader in presbyopia-correcting
IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a
CONSUMER EYE HEALTH diverse portfolio of solutions and drops.Johnson & Johnson Surgical Vision has operations in the United
States, Latin America, Asia-Pacific and Europe/Middle East/Africa regions.
Research, innovation and new-product development are the focus of our
organization. Our associates around the world are committed to expanding our
brands and fortifying our position as the worldwide leader in the industry.The Director, Regulatory Affairs is responsible for
managing, mentoring, and developing the RA team, development and implementation
of global regulatory strategies, monitoring the global regulatory environment, preparation/submission
of marketing approval applications to health authorities in order to achieve
the business objectives, and overall regulatory compliance for the site,
including, but not limited to, labeling, regulatory notifications, and
regulatory pre- and post-market compliance. The Director, RA, interacts with
internal regulatory personnel, external trade association partners, and
regulators to resolve regulatory matters ranging from pending application
negotiations to proposed legislation and guidance document ramifications for
the business. The Director, RA also builds
necessary relationships with regional regulatory colleagues and creates systems
to facilitate more efficient support of both new registrations and renewals
worldwide. The Director, RA may manage
and/or provide input into a significant portion of the department’s overall
budget, and typically oversees and manages multiple staff resources.In this role, you will:
Need to understand how to get things done and
achieve complex objectives through interaction with others in an organizational
context.
Use appropriate interpersonal styles and
communication methods to work effectively with business partners to meet mutual
goals and objectives.
Build trust by developing other people's
confidence in leadership through consistent action, values and communications;
set an environment where employees can develop trust in each other through
behaviors consistent with the Credo Values.
Establish a course of action identifying
critical inputs needed for robust regulatory strategy development; develop contingency
plans to address obstacles or potential breakdowns.
Identify and understand issues, problems, and
opportunities; compare data from different sources to draw conclusion; use
effective approaches for choosing course of action or developing appropriate
solutions; take action that is consistent with available facts, and probable
consequences.
Create a clear view of the future state; help
others understand and feel how things will be different when the future state
is achieved; influence movement and compel action toward the future state.
Use appropriate methods and interpersonal styles
to develop, motivate and guide a team toward the successful completion of a
project modifying behavior according to tasks, situations and team members
involved.
Use appropriate interpersonal styles to inspire
and guide direct reports to action; support facilitating the development of the
knowledge and skills of individual work team members; provide timely feedback,
guidance, mentoring and training to help individuals reach goals.
Transfer decision-making authority and task
responsibilities to appropriate direct reports; utilize direct reports' time,
skills, and potential effectively; create a sense of ownership of job or
projects by providing clear expectations, control of resources, and
responsibility; establish procedures to monitor the results of transfer of
responsibility or authority, assignments, or projects; take into consideration
the skills, knowledge, experience, and growth opportunities of the assigned
individual and characteristics of the assignment or project.
Continuously seek (or encourage others to seek)
opportunities for different and innovative approaches to addressing regulatory
challenges and opportunities; facilitate the use of knowledge or help from
outside the workplace (from the larger organization or outside the
organization) to identify potential problems or improvement opportunities;
advocate the need for self or others to seek a better way to address work
process issues.
Use sound knowledge of regulatory and business
strategies to gain and maintain the legal marketing status of the product
portfolio.
Qualifications
A
minimum of a Bachelor’s degree in scientific discipline is required.
A Bachelor’s degree and minimum of 10 years of
Regulatory Affairs related experience in a regulated industry OR a Master’s
degree, PhD, or PharmD and a minimum of 8 years of Regulatory Affairs related
experience in a regulated industry is required.
Previous experience with US and EU medical
device regulations is required. Experience with Canadian regulations is
preferred.
Medical Device industry experience with PMAs and
510Ks is required.
Experience with IDEs and international
registrations is strongly preferred.
Experience with software-driven
electromechanical medical devices is preferred.
Expert knowledge, understanding, and application
of principles, concepts and practice of worldwide governmental regulations is
required.
Strong organizational, communication,
negotiation and interpersonal skills is required.
Ability to effectively negotiate and influence
upper management, affiliates, Regulatory agencies, and industry to ensure that
regulatory and business needs are met is required.
This position will be located in Milpitas, CA or Santa Ana, CA with a
possibility of remote work and may
require up to 25% domestically and/or internationally.
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 LocationUnited States-California-Milpitas-Other LocationsNorth America-United States, North America-United States-California-Santa AnaOrganizationAMO Development, LLC (6242)Job FunctionRegulatory AffairsRequisition ID4789190913
