Regulatory Compliance Specialist; Remote

Employer Industry: Medical Device Manufacturing

• Salary up to $144,200 plus bonus eligibility and benefits
• Opportunity for career advancement and growth within the organization
• Flexibility to work remotely from anywhere in the U.S. with occasional onsite collaboration
• Engage in continuous improvement initiatives and contribute to meaningful projects
• Supportive work environment with a focus on compliance and regulatory standards

• Assist in reviewing customer complaints and determining reportability based on regulatory guidelines
• Prepare and submit initial, supplemental, and final adverse event reports within required timelines
• Collaborate with regulatory representatives and field teams for complaint investigations and regulatory requests
• Review complaint records for accuracy and compliance prior to closure
• Participate in investigations of nonconformities and support corrective or preventive action activities

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

• Experience with medical device adverse event reporting (e.g., MDR, MIR)
• Familiarity with regulations in a regulated industry such as medical devices or pharmaceuticals
• Knowledge of applicable U.S. 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

"We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter an employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position.

Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer."