About Us

We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enable chronic MCS therapy to be accessible to more patients across the globe.

Job Summary

BrioHealth Solutions is seeking a detail-oriented Document Control Specialist to support the document control and change management processes, as well as the Employee Training Program, within an FDA-regulated 21 CFR Part 820 environment. This role will ensure compliance with U.S. FDA and international regulations through the management of our electronic Quality Management System (eQMS). The Document Control Specialist will collaborate across multiple departments to ensure timely completion of tasks and maintain adherence to regulatory requirements. This is an onsite position located in Burlington, MA, with up to 10% travel required.

Responsibilities

Configuration Management

• Co-administer the electronic Quality Management System (eQMS) to ensure effective document and change control processes.
• Support onboarding and training of new employees on eQMS usage.
• Review change control packets and documents for accuracy, completeness, and compliance.
• Promote and enforce best practices for configuration management across the organization.
• Collaborate with teams to facilitate the timely implementation of change control processes.
• Assist in creating and updating Standard Operating Procedures (SOPs) and forms for configuration management activities.
• Ensure proper distribution and notification of document releases, revisions, and obsolescence.
• Adhere to and advocate for adherence to established configuration management procedures.

QMS Training

• Co-administer the company’s Quality Management System (QMS) training program to ensure ongoing employee compliance.
• Monitor employee training status, ensuring assignments are completed within designated timelines.

Cross-functional Collaboration

• Drive cross-functional teams to comply with document control and change management policies and procedures.
• Collaborate with functional departments to understand and address their configuration management needs.

Additional Responsibilities

• Assist Regulatory Affairs with regulatory filings, including Investigational Device Exemptions (IDE), Pre-Market Approvals (PMA), 510(k) submissions, technical files, and design dossiers.
• Support regulatory inspections and internal audits by providing requested documentation and addressing findings through corrective actions.
• Stay informed on relevant regulations, guidelines, and industry best practices related to medical device configuration management methodologies (e.g., document/change control, record control).

Qualifications

• 2-4 years of configuration management experience in the medical device industry or other regulated sectors.
• Exceptional attention to detail, critical thinking, and strong organizational skills.
• Effective communication skills, with the ability to collaborate across departments and with stakeholders.
• Skilled in prioritizing tasks and multitasking in a fast-paced environment.
• Excellent oral and written communication skills.
• Capable of managing daily tasks independently with minimal supervision.

Nice to Have

• Associate’s or Bachelor’s degree in STEM or Life Sciences.
• 2-4 years of experience in configuration management for complex electromechanical devices and systems.
• Familiarity with relevant standards, including FDA QMSR, ISO 13485, and EU MDR.