Senior Staff Regulatory Affairs Specialist (Remote)
Company: Stryker
Location: San Jose
Posted on: January 15, 2021
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Job Description:
Stryker is one of the world---s leading medical technology
companies and is dedicated to helping healthcare professionals
perform their jobs more efficiently while enhancing patient care.
The Company offers a diverse array of innovative medical
technologies, including reconstructive, medical and surgical, and
neurotechnology and spine products to help people lead more active
and more satisfying lives. We are currently seeking a Senior Staff
Regulatory Specialist to join our Endoscopy Division to be based
remotely anywhere within the United States.Who we want Dedicated
achievers. People who thrive in a fast-paced environment and will
stop at nothing to ensure a project is complete and meets
regulations and expectations. Strategic thinkers. People who enjoy
analyzing data or trends for the purposes of planning, forecasting,
advising, budgeting, reporting, or sales opportunities.
Detail-oriented process improvers. Critical thinkers who naturally
see opportunities to develop and optimize work processes ---
finding ways to simplify, standardize and automate. Self-directed
initiators. People who take ownership of their work and need no
prompting to drive productivity, change, and outcomes.Collaborative
partners. People who build and leverage cross-functional
relationships to bring together ideas, data and insights to drive
continuous improvement in functions.What you will doAs the Senior
Staff Regulatory Affairs Specialist, you will be responsible to
develop and execute global regulatory strategy for new and/or
modified medical devices including expanded indications for use, to
gain approvals for both clinical investigations and commercial
distribution. You will advise on product/project development teams
on regulatory pathway option(s) and requirements. You will be
responsible to prepare complex submissions and/or presentations to
health authorities and for any related communications and you will
develop and mentor other regulatory affairs professionals within
the department. Develop and execute global regulatory strategy for
new and/or modified medical devices including for expanded
indications for use.Prepare complex regulatory submissions and/or
presentations (i.e. pre-submissions, IDEs, 510(k)s, Technical
Files, etc.) to regulatory bodies (i.e. FDA, Notified Bodies, etc.)
and for any related communications.Opportunity to participate in
regulatory due diligence. Lead business unit in revision and/or
development of processes/ procedures for, and implementation of,
new or revised regulatory requirements based on either changes in
the business or regulatory requirements.Partner regularly with
marketing, engineering, clinical and quality on project and product
development teamsServe as a regulatory affairs representative to
improve awareness, visibility and communication on regulatory
requirements to support company goals and prioritiesWhat you need A
Bachelor---s Degree (B.S or B.A) in Engineering, Science or
equivalent focus is required.A minimum of 7 years of experience in
an FDA regulated industry required; preferably with medical
devices.A minimum of 3 years of Medical Device Regulatory Affairs
experience required.RAC certification or Advanced Degree (Masters
in Regulatory Affairs) preferred.General understanding of product
development process and design control.General understanding of
regulations applicable to the conduct of clinical trials.Previous
experience with Class II medical devices required.Experience
interacting with regulatory agencies required.Strong leadership
skills.Demonstrated success in management of global regulatory
strategy and submission activities.Demonstrated applied knowledge
of FDA and international medical device
regulations/standards/directive (i.e. European Medical Device
Regulations).Ability to understand and explain detailed regulatory
requirements among different countries and comply with constantly
changing regulatory requirements.Strong leadership
skills.LI-RemoteWork From Home: RemoteTravel Percentage: Up to
25%Stryker Corporation is an equal opportunity employer. Qualified
applicants will receive consideration for employment without regard
to race, ethnicity, color, religion, sex, gender identity, sexual
orientation, national origin, disability, or protected veteran
status. Stryker is an EO employer ---
M/F/Veteran/Disability.Stryker Corporation will not discharge or in
any other manner discriminate against employees or applicants
because they have inquired about, discussed, or disclosed their own
pay or the pay of another employee or applicant. However, employees
who have access to the compensation information of other employees
or applicants as a part of their essential job functions cannot
disclose the pay of other employees or applicants to individuals
who do not otherwise have access to compensation information,
unless the disclosure is (a) in response to a formal complaint or
charge, (b) in furtherance of an investigation, proceeding,
hearing, or action, including an investigation conducted by the
employer, or (c) consistent with the contractor---s legal duty to
furnish information.Full time
Keywords: Stryker, San Jose , Senior Staff Regulatory Affairs Specialist (Remote), Other , San Jose, California
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