Senior Regulatory Affairs Specialist (R451265)
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
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 Senior Regulatory Specialist to join our Instruments Division to be based in Portage, MI.
Who we want
Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
What you will do
As the Senior Regulatory Affairs Specialist, you will support Stryker’s Neurosurgical portfolio new product development for both US and OUS Global Regulatory release by contributing to the development and updating of regulatory strategy based upon regulatory changes. You will support the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. You will ensure regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.
This role will support the cutting edge of neurosurgical solutions, leveraging advanced software and hardware applications to improve patient outcomes and OR efficiency.
Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Participates in advocacy activities of a technical and/or tactical nature.
Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.
Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.).
Assists in the development of regulatory strategy and updates strategy based upon regulatory changes.
Evaluates proposed products for regulatory classification and jurisdiction.
Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.
Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes.
Negotiates with regulatory authorities throughout the product lifecycle.
Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation.
Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
Assists other departments in the development of SOPs to ensure regulatory compliance.
Provides regulatory input and technical guidance on global regulatory requirements to product development teams.
Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations.
Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships.
Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
Provides regulatory information and guidance for proposed product claims/labeling.
Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
Monitors the progress of the regulatory authority review process through appropriate communications with the agency.
Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.
What you need
A minimum of a Bachelor’s Degree (B.S. or B.A.) is required.
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
A minimum of 3 years of relevant experience in a legal, technical or a regulated environment required.
Previous Medical Device Regulatory Affairs experience preferred.
General understanding of product development process and design control preferred.
Thorough understanding of FDA and international medical device regulations preferred.
Ability to understand and explain detailed regulatory compliance programs and/or issues.
Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
Ability to analyze and resolve non-routine regulatory issues using independent judgment.
Ability to communicate and network with regulatory personnel to obtain relevant information.
Ability to negotiate internally and externally with FDA.
Excellent analytical and writing skills.
Strong interpersonal, written and oral communication skills.
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.