Regulatory Affairs Specialist
Cai
Summary
As a Regulatory Affairs Specialist, you will work with the FDA and international regulatory bodies on product submissions, audits, and event reporting. You will participate in cross-functional teams for new product development and changes to existing products to ensure regulatory compliance. You will also be part of the team that maintains the quality management system.
Job description
Essential Functions
- Ensure product/process compliance with the US and international requirements
- Work with Engineering on new product releases and changes to develop Regulatory Plans
- Work with Design and Development Project teams to ensure compliance with Design Control Requirements
- Work with the FDA on product submissions
- Initiate US and International product submissions and registrations
- Participate in internal and external audits
- Reporting of adverse events to FDA
- Other duties as assigned
Competencies/Success Factors
- Business or Job-Specific Knowledge
- Learning Ability
- Results Focus/ Output Orientation
- Time Management
- Interpersonal Communication
- Handling Conflict or Difficult People
- Ethics, Integrity, Values
- Problem-Solving
Supervisory Responsibility
This position has no supervisory responsibilities.
Work Environment
This job operates in a professional office environment and manufacturing/distribution environment.
Travel
This position requires up to 10% travel. Some of the travel may be international.
Required Education and Experience
- Bachelor's degree from a four-year college or university, preferably an engineering or technical degree or equivalent work experience
- Good communication skills at all levels (written and verbal)
- Ability to plan and manage multiple tasks/projects
Preferred Education and Experience
- Master's degree a plus
- Co-op or internship preferred
Requirements
- Bachelor's degree from a four-year college or university, preferably an engineering or technical degree or equivalent work experience
- Good communication skills at all levels (written and verbal)
- Ability to plan and manage multiple tasks/projects
- Master's degree a plus
- Co-op or internship preferred
Company overview
CAI is a global professional services firm specializing in operational readiness and excellence for regulated industries, with a primary focus on pharmaceutical manufacturing and life sciences. Headquartered in Indianapolis, Indiana, the company provides comprehensive consulting and implementation services to accelerate facility startups, ensure regulatory compliance, and optimize operational performance. CAI's expertise spans commissioning, qualification, validation (CQV), quality risk management, digital transformation, and workforce capability development. The firm employs a six-pillar framework for operational readiness that addresses strategy leadership, execution excellence, facility and equipment readiness, digital maturity, quality advancement, and workforce capability. With a global presence across North America, Europe, Asia, and Australia, CAI serves leading pharmaceutical and biotechnology companies, helping them navigate complex regulatory environments and achieve first-time-right launches. The company leverages advanced technologies including AI, digital twins, and data analytics to enhance operational efficiency and reduce time-to-market for critical healthcare products.