Regulatory Reporting Specialist (Hybrid)

Regulatory Reporting Specialist

Stryker is currently seeking a Regulatory Reporting Specialist to join our Joint Replacement Division to be based hybrid in Weston, FL.

What you will do

As the Regulatory Reporting Specialist, you will be responsible for ensuring the organization's compliance with FDA, European, and global requirements governing adverse event reporting. In this role, you will gain the clinical and regulatory experience required to accurately assess the reportability status of incoming complaints associated with hip, knee, limb salvage, and robotic devices utilizing risk documentation. In addition to managing adverse event reporting activities, you will have the opportunity to collaborate with several post-market teams and support continuous improvement and efficiency projects.

• Review reports of customer complaints and assess them for MDR / MIR reportability to FDA / Competent Authorities
• Ensure initial and follow up reports are submitted to Regulatory Agencies within required timelines
• Partner with Quality Complaint-Handling personnel to assure the complaint records contain all required information to make a compliant regulatory decision
• Support interactions with Regulatory Agencies as required
• May aid in updating current procedures / processes or assist in creating new procedures / processes
• Review and analyze data for trending purposes
• Track metrics on process timeliness and effectiveness
• Participate in Post-Market Compliance initiatives

What you need

Required

Preferred

Travel Percentage : 10% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M / F / Veteran / Disability.