Regulatory Affairs Coordinator II

Employer Industry: Medical Device Technology

• Salary up to $31.70 per hour
• Comprehensive benefits package, including health, dental, and retirement plans
• Opportunity for career advancement and growth within the organization
• Supportive and collaborative work environment focused on improving patient outcomes
• Chance to make a meaningful impact on patient care and safety in the medical field

• Maintain Post Market Surveillance documentation in accordance with regulatory requirements
• Identify complaints and determine reportability to regulatory authorities
• Complete and submit documentation for reportable events within required timelines
• Coordinate and maintain closure of complaint records in the Post Market Surveillance system
• Communicate effectively with customers and team members regarding complaint reporting

• High School Diploma required
• 3 years of experience in the Healthcare or Medical Device Industry preferred
• Knowledge of FDA 21 CFR Part 803 and experience in an FDA-regulated environment preferred
• Strong verbal and written communication skills
• Proficiency in Microsoft Tools, including Outlook, Teams, Excel, Access, and Word

• Associate’s or Bachelor’s degree preferred
• Quality or Regulatory experience in Medical Devices preferred
• Analytical and forward‑thinking mindset
• Ability to take constructive feedback for continuous improvement
• Positive attitude and strong attention to detail

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 parlé for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the Employer‑of‑Record for this position; our role is to connect outstanding candidates with a top‑tier employer.