Job Description

Stryker is one of the worlds 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 preferably or remotely anywhere within the United States.

Strykers Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. 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. If you join our organization; will be working to Make Stroke History. Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg.

Who we want

* 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.

* 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.

* Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

What you will do

As the Principal Regulatory Affairs Specialist, you will be responsible to prepare complex submission to gain approvals for clinical studies and commercial distribution in in one or more of the following geographic regions: United States, Europe, Japan, Canada, and other international countries.

* Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.

* Evaluate the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.

* Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.

* Identify the need for new regulatory procedures, SOPs, and participates in development and implementation.

* Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.

* Assist other departments in the development of SOPs to ensure regulatory compliance.

* Provide regulatory input and technical guidance on global regulatory requirements to product development teams.

* Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.

* Assess the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations.

* Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.

* Provide knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships.

* Identify, monitor and submit applicable reports or notifications to regulatory authorities during the clinical research process.

* Provide regulatory information and guidance for proposed product claims/labeling.

* Communicate and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.

* Work with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.

What you need

* A Bachelors Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.

* A minimum of 9 years of experience in an FDA regulated industry required; preferably within medical devices.

* A minimum of 7 years of Regulatory Affairs experience required.

* RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

* General understanding of product development process and design control.

* Understanding of regulations applicable to the conduct of clinical trials required.

* Thorough understanding of FDA and international medical device regulations.

* Previous experience with Class III medical devices preferred.

* Previous experience drafting an IDE/PMA submission preferred.

* RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

* Experience interacting with regulatory agencies preferred.

* Knowledgeable in areas such as regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally; submission, registration, obtaining approval, documentation, compliance, post marketing surveillance/vigilance; and distribution.

* Ability to comply with constantly changing regulatory procedures 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.

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