Regulatory Affairs / Quality Assurance (RA/QA) Associate

Role: RA/QA Associate

Location: Huntington Beach - Onsite Full time

Salary Range: $60,000 - $70,000

 

 

Position Summary

We are seeking an organized and detail-oriented Regulatory Affairs / Quality Assurance (RA/QA) Associate to support the Regulatory Affairs and Quality Assurance department. The ideal candidate will assist in preparing regulatory and quality documentation, managing controlled records, and supporting compliance with applicable standards and regulations. This role provides an excellent opportunity to gain hands-on experience in RA/QA and grow within the medical device industry.

 

Key Responsibilities

• Prepare Post-Market Surveillance Reports.
• Prepare Usability Reports.
• Prepare Clinical Evaluation Reports.
• Prepare Post-Market Clinical Follow-Up (PMCF) Reports.
• Prepare Periodic Safety Update Reports (PSURs).
• Handle and document medical device complaints in compliance with regulatory requirements.
• Review controlled documents from various departments for compliance and accuracy, including:

• Design control documents

• Process validation documents

• Controlled document naming/numbering assignments

• Document change control tracking and maintenance

• Maintain accurate records of all controlled documents.

 

Qualifications

• Bachelor’s degree in engineering or a related field.
• Strong attention to detail and excellent organizational skills.
• Ability to manage multiple tasks and meet deadlines.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work both independently and as part of a collaborative team.
• Familiarity with ISO 13485 and FDA Quality System Regulations (preferred but not required).

 

What We Offer

• Opportunity to grow and advance within the RA/QA field.
• A collaborative and supportive work environment.
• Training and mentorship from experienced professionals.

 

Equal opportunity employer

SprintRay is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable law. We are committed to providing an inclusive and welcoming environment for all employees.

About SprintRay:

SprintRay is a highly collaborative environment where innovative people have the freedom to satisfy their curiosity by finding creative solutions to hard problems. If you are a relentless problem solver who wants to shape the future of 3D printing, join SprintRay! Together, we can revolutionize the next 100 years of manufacturing and empower future generations of doctors, designers, and makers all over the world.

 

To All Recruitment Agencies:

Without a written agreement signed by an officer of SprintRay: a) SprintRay does not accept resumes from recruiting agencies, headhunters, or any other party expecting payment in the event SprintRay speaks with or hires a candidate from such submitted resume; b) SprintRay is not responsible for any fees related to unsolicited resumes or related Terms of Service, and c) Unsolicited resumes received will be considered the property of SprintRay and will be processed accordingly.