Staff Regulatory Affairs Specialist (Remote) (R448571)
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. 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
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. 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.
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
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.
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 Staff Regulatory Affairs Specialist, you will be primarily 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 possibly other international countries. In addition, you may be requested to manage regulatory deliverables for various projects and submissions such as EU MDR. This includes participating as a contributing team member, tracking the execution of the projects, and developing dashboards, metrics and reports for communication to management.
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.
Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.).
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.
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.
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.
What you need
A Bachelor’s Degree (B.S or B.A) required; preferably in Engineering, Science or equivalent focus.
A minimum of 5 years of experience in an FDA or highly regulated industry required.
A minimum of 3 years in a Regulatory Affairs role required.
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
Project Management Training or Certification preferred.
Knowledge of product development process and design control required.
General understanding of regulations applicable to the conduct of clinical trials required.
Previous experience with US Class II/III medical devices preferred.
Previous experience drafting 510(k)s preferred.
Experience authoring regulatory submissions for product approval required.
Experience interacting with regulatory agencies preferred.
Strong problem-solving skills: ability to identify and execute effective solutions.
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.
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.