Senior Regulatory Affairs Specialist

Stryker is hiring a Senior Regulatory Affairs Specialist to support Sports Medicine in Denver, CO or San Jose, CA ! In this role, you will develop and implement regulatory strategies, ensure compliance across the product lifecycle, manage regulatory submissions, advise stakeholders on regulatory requirements, and engage with regulatory authorities to resolve issues and support market access. What you will do Develop and update regulatory strategies at the local, regional, and global levels by monitoring regulatory intelligence and emerging requirements. Determine product classification, submission requirements, and approval pathways, preparing and submitting regulatory filings in alignment with applicable guidelines. Assess the regulatory landscape and provide guidance across the product lifecycle to support compliant development, manufacturing, and commercialization. Identify potential regulatory obstacles, anticipate upcoming issues, and recommend practical solutions to maintain compliance and support market access. Review quality, preclinical, and clinical documentation to ensure readiness for regulatory submissions and consistency with regulatory expectations and product claims. Evaluate proposed device modifications to determine necessary regulatory actions. Support interactions with regulatory authorities by contributing to communication, tracking submission progress, and preparing required documentation. Provide regulatory input on product labeling and claims, ensuring that clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims. What you need Required Bachelors degree Minimum of 3+ years of regulatory affairs experience within a regulated industry (e.g., medical devices, IVDs, pharmaceuticals, biotechnology, or healthcare products). Demonstrated experience in project management, regulatory writing, and coordinating and executing regulatory submissions and deliverables. Preferred Bachelors degree in Regulatory Science, or technical discipline (Engineering or Life Sciences) Experience engaging with regulatory authorities to support submissions, respond to inquiries, and facilitate successful interactions throughout the product lifecycle. RAC(s) certification United States of America Pay Ranges US10: $91,600 - $152,700 USD Annual US30: $108,300 - $180,400 USD Annual Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. #J-18808-Ljbffr