Staff Regulatory Affairs Specialist

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $100.5k - $167.5k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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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 regulatory strategies for pre-market and post-market products to maintain market access across global regions • Evaluate regulatory requirements and identify submission pathways for product changes • Author and submit regulatory documents, including FDA submissions and international dossiers • Assess global regulatory impact of product or process changes and coordinate required notifications or submissions • Partner with cross-functional teams on regulatory agency interactions, responses, meetings, and documentation • Monitor regulatory intelligence and update strategies based on evolving global requirements • Maintain and update standard operating procedures to ensure compliance and improve regulatory processes • Provide regulatory guidance to stakeholders on product lifecycle activities and applicable standards • Support maintaining medical devices on the market and ongoing compliance • Travel approximately 20%

🎯 Requirements

• Bachelor’s Degree (B.S. or B.A.) • Minimum 4 years of experience in an FDA-regulated industry • Minimum 2 years of experience in regulatory affairs • Applied knowledge of FDA and international medical device regulations/standards, such as EU MDR • Experience with Class II or Class III medical devices (preferred) • Experience authoring 510(k) submissions or equivalent regulatory filings (preferred) • Experience interacting with regulatory agencies or supporting regulatory meetings (preferred) • Bachelor’s degree in engineering, science, or related field (preferred) • Regulatory Affairs Certification (RAC) or advanced degree in regulatory affairs or related discipline (preferred)

🏖️ Benefits

• Remote work arrangement • Travel reimbursement/coverage implied by 20% travel requirement