Staff Regulatory Affairs Specialist, Mako and Enabling Technologies

🔥 2 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $105.3k - $175.5k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Stryker

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1941

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Stryker is a global leader in medical technology, providing innovative products and services across the healthcare sector. With a presence in countries across the Americas, Asia Pacific, Europe, and the Middle East & Africa, Stryker offers a wide range of medical technologies, including orthopedic implants, surgical equipment, and advanced hospital devices. The company is committed to improving patient outcomes and healthcare efficiency. Stryker continues to expand its global reach, offering localized solutions to meet diverse healthcare needs worldwide.

📋 Description

• Develop and execute global regulatory strategies for new products, product changes, and lifecycle management activities • Participate in product development teams to incorporate U.S., European, and international regulatory requirements throughout development phases • Evaluate product classifications, regulatory pathways, and jurisdictional requirements for medical devices and related technologies • Author and submit regulatory filings, including FDA submissions, international registrations, and supporting documentation for product approvals • Review quality, preclinical, and clinical documentation for submission readiness and regulatory compliance • Partner with global regulatory affiliates on registrations, market expansions, and post-market regulatory activities • Lead interactions with regulatory authorities and notified bodies, including responses, submissions, and agency communications • Review product labeling, marketing materials, and product claims for compliance • Mentor junior regulatory team members on regulatory processes and best practices

🎯 Requirements

• Bachelor’s degree in Engineering, Sciences, Regulatory Affairs, or a related field • Minimum 4 years of experience in an FDA-regulated industry • Minimum 3 years of Regulatory Affairs experience • Experience preparing regulatory submissions for product approvals • Preferred: Regulatory Affairs Certification (RAC) and/or Master’s degree in Regulatory Affairs or a related field • Preferred: Experience supporting Class II and/or Class III medical devices • Preferred: Experience authoring FDA 510(k) submissions • Preferred: Experience interacting directly with regulatory agencies and notified bodies

🏖️ Benefits

• Remote position • Preference for candidates located in the U.S. Eastern Time Zone • Travel Percentage: None