Staff Regulatory Affairs Specialist

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 Staff Regulatory Affairs Specialist to join our Neurovascular Division to be based in Fremont, CA or anywhere within the United States.Stryker’s 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 wantDetail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.

Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.

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.

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.

What you will doAs the Staff Regulatory Affairs Specialist, you will be responsible for the coordination and preparation of change assessments and document packages for regulatory submissions 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.

Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.

Assist in the development of regulatory strategy and updates strategy based upon regulatory changes.

Evaluate proposed products for regulatory classification and jurisdiction.

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

Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.

Negotiate with regulatory authorities throughout the product lifecycle.

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 propose plans/strategizes (if appropriate) for changes that do not require submissions.

Ensure that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.

Prepare and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.

Monitor the progress of the regulatory authority review process through appropriate communications with the agency.

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 needA Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.

A minimum of 5 years of experience in an FDA regulated industry required; preferably with medical devices.

A minimum of 4 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.

Thorough understanding of FDA and international medical device regulations.

Previous experience with Class II/III medical devices preferred.

Previous experience drafting regulatory submissions required.

Experience interacting with regulatory agencies required.

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.

Work From Home: RemoteTravel 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.Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com