Overview
Regulatory Affairs Specialist Jobs in Irvine, CA at Intellectt Inc
Title: Regulatory Affairs Specialist
Company: Intellectt Inc
Location: Irvine, CA
Job Title: Regulatory Affairs Coordinator III (Medical Devices)
Location: Irvine, CA 92618
Employment Type: Contract
Duration: 6+ Months
Job Summary
The Regulatory Affairs Coordinator III independently supports and executes regulatory activities for U.S. Class II and EU Class II and/or Class III medical devices throughout the product lifecycle. This role is responsible for preparing and maintaining regulatory submissions and technical documentation, supporting compliance with FDA and EU MDR requirements, and collaborating with cross-functional teams to support regulatory objectives. The position operates in a hybrid work environment with limited supervision.
Responsibilities
- Prepare, review, maintain, and support regulatory submissions and technical documentation for medical devices in U.S. and international markets
- Support regulatory compliance activities for Class II and Class III medical devices in accordance with FDA regulations and EU MDR requirements
- Maintain and update EU MDR technical files and related regulatory documentation
- Collaborate with cross-functional teams including Quality, Engineering, Clinical, Manufacturing, and Marketing to support product lifecycle activities
- Monitor and interpret applicable global regulatory requirements and communicate updates to relevant stakeholders
- Support product registrations, renewals, amendments, and change control activities
- Ensure documentation accuracy, completeness, and compliance within document management systems
- Participate in internal and external audits and regulatory inspections as needed
- Assist with regulatory strategy execution for new products, product modifications, and sustaining activities
- Prioritize and manage multiple assignments in a fast-paced environment while meeting project timelines
Required Qualifications
- Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field
- 5–7 years of Regulatory Affairs experience within the medical device industry
- Direct experience supporting U.S. Class II medical devices and EU Class II and/or Class III medical devices
- Hands-on experience supporting EU MDR technical files and related documentation
- Knowledge and understanding of global regulations relevant to medical devices
- Experience preparing and maintaining regulatory submissions and technical documentation
- Proficiency with Microsoft Office applications and document management systems
- Strong written and verbal communication skills
- Strong organizational, analytical, and critical thinking skills
- Ability to manage competing priorities and work independently with limited supervision
- Ability to collaborate effectively within cross-functional and interdepartmental teams
- Coursework, seminars, and/or formal government or trade association regulatory training preferred
Work Requirements
- Ability to work in a hybrid remote/in-office environment
- Ability to maintain confidentiality and handle sensitive regulatory documentation
- Ability to communicate professionally with internal and external stakeholders
- Must be authorized to work in the United States without current or future employer sponsorship
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role, consistent with applicable law
Salary/Rate:
$40.00–$45.00 per hour on a W-2 basis
In accordance with applicable federal, state, and local laws, the compensation range provided reflects the anticipated hourly rate for this position at the time of posting. Actual compensation may vary based on factors including experience, qualifications, skills, education, and business needs.
Benefits:
This is a contract position. No employer-provided benefits are offered unless otherwise required by applicable law.
Equal Opportunity Employer:
The employer is an Equal Opportunity Employer and considers all qualified applicants for employment without regard to race, color, religion, creed, sex, gender, pregnancy, sexual orientation, gender identity or expression, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, citizenship status, or any other characteristic protected by applicable federal, state, or local law.
Application:
Qualified candidates are encouraged to apply with an updated resume detailing relevant Regulatory Affairs and medical device industry experience. Only candidates whose qualifications most closely align with the position requirements may be contacted for further consideration.
