Principal Regulatory Affairs Specialist

Stryker - Fremont, CA

Full-time
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 Principal Regulatory Affairs Specialist to join our Neurovascular Division to be based in Fremont, CA.

At Stryker Neurovascular, our mission centers on Complete Stroke Care which aims to reverse the trend of 120,000 – a staggering 1 in 20 – US deaths caused by over nearly 800,000 US strokes per year. We are the market leader in cutting edge, less invasive neuro-technologies that not only improved patient outcomes, but also led to double digit divisional and Stryker’s overall business growth. Our stent retriever technologies were proven with Class 1, Level A evidence to reduce death and disability in 5 recent, landmark clinical trials that spurred a major overhaul of the ASA/AHA Guidelines for treating acute ischemic stroke. In February 2019, Stryker Corporation (NYSE: SYK) announced that for the ninth consecutive year has been named as one of the FORTUNE 100 Best Companies to Work For ranking 11 out of 100. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg

Who we want

Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
What you will do

As the Principal Regulatory Affairs Specialist, you will responsible for providing leadership, organization and coordination of the Neurovascular APAC regulatory strategies and submissions to support high impact product launches and ongoing market access.

Develop regulatory strategies for product registrations and product change registrations in Japan.
Communicate and interface directly or indirectly with PMDA or other designated authorities in Japan in pre-consultations and formal consultations to ensure timely product approvals.
Provide regulatory advice and country specific requirements for new product development, product change, supply chain management, product launch, and product recalls.
Author and prepare documentation including but not limited to: Shonin and Ninsho submissions, package inserts, etc.
Perform and assist data integrity review with relevant function teams.
Maintain current knowledge of Japan medical device regulations, interpret policies and guidance and correctly applies them as regulatory activities.
Facilitate PMDA audits required for new product registrations.
What you need

A minimum of a Bachelor’s Degree (B.S. or B.A.) required.
A minimum of 9 years of experience in regulated industry required.
A minimum of 5 years of Regulatory Affairs experience required.
Previous experience supporting global submissions including Japan submission experience required.
Ability to negotiate internally and externally with global Health Authorities including Japan PMDA.
Japanese language fluency required.
RAC certification or Advance Degree (Master in Regulatory Affairs) preferred.
Excellent interpersonal communication, collaborative team work, and negotiation skills.
Ability to rapidly build product knowledge and understanding of highly technical and scientific regulatory activities.
Ability to understand and explain detailed regulatory positions and strategies.
Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
Ability to communicate and network with regulatory and cross-functional personnel to obtain relevant information.
Excellent analytical and writing skills.
Strong interpersonal, written and oral communication skills.
Work From Home: No
Travel Percentage: 20%
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.