Regulatory Compliance Specialist (Remote)

Stryker • Colorado Springs, CO

1d • Remote

About The Position

Stryker is hiring a Regulatory Compliance Specialist for our Endoscopy division primarily supporting our Stryker Sustainability Solutions business unit. In this role, you will support post‑market regulatory reporting activities to help ensure the continued safety and effectiveness of Stryker products in the field. Your responsibilities will include evaluating customer complaints for regulatory reportability, preparing and submitting adverse event reports, and responding to inquiries from global regulatory agencies. For events that require reporting, you will ensure submissions are clear, accurate, and delivered within required timelines. For non‑reportable events, you will use available data and collaborate with clinicians and subject matter experts to develop well‑supported rationales. You will also contribute to continuous improvement efforts by participating in team and cross-functional projects and initiatives that enhance adverse event reporting processes. This is a remote position with a preference for candidates located near one of our key office locations (Tempe, AZ; Greenwood Village, CO; Flower Mound, TX; San Jose, CA) to support occasional onsite needs, in‑person collaboration, and professional development. However, candidates may reside anywhere within the United States.

Requirements

• Bachelor’s degree, preferably in science, engineering or related field of study.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook, Teams).

Nice To Haves

• Experience with medical device adverse event reporting (e.g. MDR, MIR).
• Experience in a regulated industry, such as medical devices or pharmaceuticals.
• Applied knowledge of applicable US and international regulations and standards (e.g., 21 CFR 803, EU MDR 2017/745, ISO 13485).
• Experience with Microsoft Power Automate and/or Power BI.

Responsibilities

• Assist in reviewing customer complaints and determining MDR/MIR reportability based on regulatory guidelines.
• Help prepare and submit initial, supplemental, and final adverse event reports within required regulatory timelines.
• Support team efforts to ensure all adverse event submissions meet global regulatory deadlines.
• Work with regulatory representatives, customers, and field teams to gather additional information for complaint investigations and regulatory requests.
• Review complaint records prior to closure to help ensure accuracy and compliance with relevant regulations and standards.
• Participate in investigations of nonconformities and contribute to corrective or preventive action activities.
• Provide support during internal and external audits, including organizing documentation and assisting with data preparation.
• Contribute to process improvements, maintain familiarity with applicable regulations, and support training or systems use (e.g., TrackWise) as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level