Regulatory Affairs Coordinator

Position Summary

The Regulatory Affairs Coordinator provides operational and administrative support to the Regulatory Affairs function, with a primary focus on assisting in 510(k) submissions, regulatory documentation, and compliance activities for Class II medical devices.

This role supports the preparation, organization, and maintenance of regulatory files, ensuring accuracy, completeness, and alignment with FDA and global regulatory requirements. The Coordinator works cross-functionally with internal teams and supports communication with global headquarters (OHQ) and external partners.

This is an entry to mid-level role designed to build foundational experience in regulatory affairs within a highly regulated medical device environment.

Key Responsibilities

510(k) Submission & Regulatory Support

• Assist in the preparation and submission of regulatory documents to ensure compliance with local and international regulations
• Format and proofread regulatory documentation, and update regulatory databases, and tracking tools for ongoing projects
• Collaborate with team members to support the regulatory affairs department in various projects and tasks
• Support responses to regulatory inquiries and requests for additional information
  
  

Regulatory Documentation & Compliance

• Maintain and update regulatory documentation within document control systems
• Support product Registrations and listings as it relates to product changes and/or new product launches
• Support labeling and promotional material review by organizing documentation and tracking approvals
• Ensure documentation aligns with applicable standards (FDA, ISO 13485, ISO 14971, IEC 62304 etc.)
• Maintain organized regulatory files to support audits and inspections
  
  

Administrative & Coordination Support

• Provide administrative support to the Regulatory Affairs Manager, including: Scheduling meetings and coordinating cross-functional reviews
• Tracking action items and follow-ups
• Preparing meeting materials and summaries
• Coordinate with internal teams (R&D, Quality, Marketing, Supply Chain) to gather required documentation
• Support communication with Omron Headquarters (OHQ) and external partners as needed
  
  

Quality System & Process Support

• Assist with internal audits and regulatory inspections by preparing documentation
• Support change control, document updates, and recordkeeping activities
• Help track regulatory commitments, deadlines, and compliance requirements
  
  

Qualifications

Education

• Bachelor’s degree preferred in:Life Sciences (Biology, Chemistry, etc.)Biomedical Engineering Regulatory Affairs or related field
  
  

Experience

• 3 - 5 years of experience in: Regulatory affairs, quality, or compliance in a regulated industry (medical device preferred)OR relevant internship/co-op experience in medical device or healthcare
• Exposure to FDA regulations or 510(k) submissions is a plus
  
  

Technical Skills

• Proficiency with Microsoft Office suite (Word, Excel, PowerPoint)
• Experience with document control systems or regulatory databases preferred
• Strong formatting and document management skills
  
  

Core Competencies

• Strong attention to detail and organization
• Ability to manage multiple tasks and deadlines
• Effective written and verbal communication
• Ability to follow structured processes and ensure compliance
• Collaborative team player with a proactive mindset
  
  

Preferred Qualifications

• Familiarity with: FDA 21 CFR regulations and applicable guidance documents (e.g., device classification, 510(k), labeling)ISO 13485 Quality Management Systems
• Basic regulatory submission types (510(k), exemptions, LTFdocumentation)
• Interest in pursuing a career in Regulatory Affairs (e.g., RAC certification pathway)
  
  

Omron is an Equal Opportunity Employer. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, we comply with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.