Job Details

Stryker

http://www.stryker.com

Staff Regulatory Affairs Specialist, Pharmaceuticals

Occupation: Equipment/Technology Specialist

Specialty: Equipment and Facilities Specialist

Visa sponsorship provided: No

Location: San Jose, California, United States

Why RA/QA at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

We are currently seeking a Staff Regulatory Affairs Specialist, Pharmaceuticals to join our Endoscopy Division to be based in San Jose, CA or 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.
Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.
Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

What you will do

As a Staff Regulatory Affairs Specialist Pharmaceuticals, you will be responsible for completing thorough regulatory assessments and preparing complex submissions pertaining to pharmaceutical product approvals for clinical investigations, commercial distribution and/or new/expanded indications by FDA, Health Canada and other regulatory bodies. You will advise product / project development teams on regulatory pathway option(s) and requirements. You will be responsible for presentations to health authorities and any related communications.

Develop regulatory submission strategy and update as needed through investigation and evaluation of regulatory history/ background, classification, disease, and/ or harmonized/ recognized standards, in order to assess regulatory implications for approval.

Assess the acceptability of nonclinical and clinical documentation for submission filings to comply with regulatory requirements for clinical investigations and marketing applications and corporate goals, to secure submission approval.
Prepare submissions and/ or documents supporting submissions, with focus on nonclinical/ clinical dossiers, to gain approvals for clinical investigations and/ or commercial distribution, such as: CTAs, ITAs, INDs, (s)NDAs, DINAs, Marketing Authorizations (MA) and Letters to File etc.
Ensure that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding regulatory agency meetings, potential regulatory pathways, clarification, and follow-up of submissions under review.
Evaluate critically nonclinical/ clinical data, published medical and scientific literature, to support and generate scientifically fair-balanced documents, such as literature reviews, meta-analyses, CTD nonclinical and clinical summaries and product benefit/risk assessments.
Advise project and/ or project teams on regulatory requirements for nonclinical and clinical data requirements for clinical study applications and/ or marketing applications.
Provide regulatory information and guidance for proposed product claims/labeling.
Evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.

What you need

A Bachelor’s Degree (B.S or B.A) required; preferably in Health Science or equivalent focus.
A minimum of 5 years of experience in an FDA regulated industry required; preferably with pharmaceuticals.
A minimum of 2 years of pre-market Regulatory Affairs experience.
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
Previous experience drafting regulatory submissions preferred.
Ability to comply with constantly changing regulatory and clinical environments and prioritize work effectively.
Ability to analyze and resolve non-routine regulatory issues using independent judgment.
Excellent analytical and writing skills.
Excellent interpersonal, written and oral communication skills.
Effective organizational skills.
Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.