Staff Regulatory Affairs Specialist
Stryker CorporationFull time Full day
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 Specialist to join our Neurovascular Division to be based either in Fremont, CA or remotely 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 want
- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
- Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
- Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
- Self-directed imitators. 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.
- 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 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.
- Compare regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes.
- Negotiate with regulatory authorities throughout the product lifecycle.
- 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.
- 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.
- Assessed changes to marketed devices and determine impact on global regulatory status
- 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.
- 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 need
- A Bachelor's Degree (B.S or B.A) in Engineering, Science or relevant focus is required.
- A minimum of 5 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 required.
- General understanding of regulations applicable to the conduct of clinical trials required.
- Thorough understanding of FDA and international medical device regulations required.
- Previous experience with Class II/III medical devices preferred.
- Previous experience drafting 510(k)s required.
- Experience authoring regulatory submissions for product approval 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: Remote
Travel 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.
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