Document Control Specialist

About Bright Uro: 

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. 

Duties and Responsibilities:  

We are seeking a junior Document Control Specialist to join our team. The ideal candidate will have 0-2 years of documentation control experience in the biomedical and/or biotech industries; those without experience should have education in writing and process management, and have an interest in the medtech industry. This role is critical to ensuring the accuracy, compliance, and organization of the company's documentation processes. 

This is a local role, working 5 days per week in-person at our Irvine, CA office. 

• 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 

Required Qualifications:  

• 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 Have: 

• 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 

Physical Requirements:  

• Must be able to work extended amounts of time standing or sitting based on projects and priorities