Document Control Specialist

Bright Uro • Irvine, CA

13d • $62,000 - $80,000 • Onsite

About The Position

Bright Uro is a fast-growing medical device startup headquartered in Irvine, CA. Our mission is to improve the lives of millions affected by lower urinary tract symptoms (LUTS) by developing cutting-edge diagnostic technology that combines advanced hardware, intuitive software, and powerful data analytics – making it easier for clinicians to gain actionable insights while delivering a better patient experience. Our passion lies in advancing urologic care through innovation and building a collaborative, dynamic team to bring transformative solutions to life.

Requirements

• Bachelor's degree
• Interest in documentation control within the biomedical and/or biotech industries
• Excellent verbal and written communication skills, with accuracy in grammar, spelling, and punctuation
• High personal/professional integrity, trustworthiness, strong work ethic, and ability to work independently
• Ability to work in a dynamic and collaborative environment and maintain a results-oriented, positive, “can-do” attitude and ability to work well under pressure
• Strong organizational and multitasking skills, with a high level of attention to detail and proactive approach to problem-solving
• Proficiency in word processing and spreadsheet software. We use Microsoft Office (Outlook, Word, Excel, PowerPoint) and MS Teams, and can train you if you have experience in similar platforms
• A desire to learn; since this is an entry-level role, we will be training you to for the role and how you can excel in it

Nice To Haves

• CAD experience
• Understanding of regulatory requirements and standards (e.g., FDA, ISO)
• Experience with documentation management software and tools (file storage, e.g., SharePoint)
• Experience with electronic document management systems (EDMS) and electronic Quality Management Systems (eQMS)
• Prior experience in a startup work environment

Responsibilities

• Manage and maintain documentation systems, ensuring all documents are up-to-date, accurate, and compliant with industry standards and regulations
• Coordinate the creation, review, approval, and distribution of documentation related to medical devices, including technical manuals, regulatory submissions, and quality assurance records
• Collaborate with cross-functional teams, including R&D, Manufacturing, Quality Assurance, and Regulatory Affairs, to ensure documentation meets project timelines and requirements
• Implement and maintain document control procedures, including revision/version control, document tracking, and archiving
• Conduct regular audits of documentation systems to ensure compliance with internal and external standards
• Provide communication and support to staff on documentation processes and best practices
• Coordinate employee training for new and revised procedures utilizing the eQMS capabilities
• Assist in the preparation and submission of regulatory documents to relevant authorities
• Ensure confidentiality and security of sensitive information
• Assist during quality systems internal audits
• Assist the audit team during external audits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level