Principal Regulatory Affairs Specialist (Remote)

About Stryker

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 Principal Regulatory Affairs Specialist to join our Instruments Division to be based in Portage, MI or remotely anywhere in the United States.

Who we want

• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

• 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 Principal Regulatory Affairs Specialist, you will support Stryker’s Spine Advanced Guidance Technologies 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 navigated spine surgery solutions, leveraging advanced software, hardware, and artificial intelligence applications to improve patient outcomes and OR efficiency.

• Report observations/ problems clearly and concisely and takes appropriate actions.

• Demonstrate developing of advanced technical leadership skills within the department.

• Possess and applies a broad knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.

• Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.

• Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance.

• Plan, conduct and execute assignments, reviewing progress and evaluating results.

• Assist in SOP development and review.

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

• Provide regulatory input new product development and product lifecycle planning.

• Evaluate regulatory impact of proposed changes to launched products.

• Demonstrate understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications.

• Determine and communicate submission and approval requirements.

• Participate in risk-benefit analysis for regulatory compliance.

• Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.

• Maintain annual licenses, registrations, and listings.

• Review regulatory aspects of contracts.

• Ensure compliance with product post-approval or clearance requirements.

• Approve labeling, advertising and promotional items for compliance before release.

• Review publicly disseminated information to minimize regulatory exposure.

• Review product claims and preserving confidentiality of applicable product information.

• Provide regulatory input for and appropriate follow-up to inspections and audits.

• Assist in the development and implementation of SOPs and systems to track and manage product-associated events.

• Review change management to determine the level of change and potential submission requirements.

• Identify product-associated problems and developing proposals for solutions.

• Advise responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications.

• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.

• Assess the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements.

• Monitor impact of changing regulations on submission strategies.

• Identify issues early in the submission preparation process that could impact product launch.

• Compile, prepare, reviewing and submit regulatory dossiers to authorities.

• Participate in negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance.

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 9 years of relevant experience in a legal, technical or a regulated environment required.

• A minimum of 6 years of Medical Device Regulatory Affairs experience required.

• Previous experience supporting submissions to the FDA.

• General understanding of product development process and design control required.

• Thorough understanding of FDA and international medical device regulations required.

• Experience authoring regulatory submissions for product approval required.

• Experience interacting with regulatory agencies 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​.

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