Job Description

About Us:

Bright Uro is a startup, medical device technology company headquartered in Irvine, CA. Our mission is to create meaningful change for millions of people dealing with lower urinary tract symptoms (LUTS) by building the next generation of diagnostic devices for Urology. By utilizing advanced hardware, software, and data science, our goal is to unlock new data streams and offer actionable insight for clinicians while prioritizing the patient experience.

Essential Duties and Responsibilities:

We are seeking a skilled and experienced Document Control Specialist to join our team. The ideal candidate will have a minimum of 5 years of documentation control experience in the biomedical and/or biotech industries. This role is critical to ensuring the accuracy, compliance, and organization of the company's documentation processes.

• 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 training 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.

Education and/or Work Experience Requirements:

• Associate's or Bachelor's degree is required.
• 5+ years of experience in documentation control within the biomedical and/or biotech industries.
• Strong understanding of regulatory requirements and standards (e.g., FDA, ISO).
• Proficient in documentation management software and tools (file storage, e.g., SharePoint).
• Experience with electronic document management systems (EDMS) and electronic Quality Management Systems (eQMS).
• CAD experience is a plus.

Additional Requirements:

• Excellent verbal and written communication skills – including the ability to contribute technically to and work within cross-functional team environments.
• 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 Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); familiarity with Microsoft Teams is a plus. 
• Prior startup experience preferred but not required.

Physical Requirements:

• Must be able to lift up to 10 lbs.
• Must be able to work extended amounts of time standing or sitting based on projects and priorities. 

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