Senior Regulatory Affairs Specialist

BrioHealth Solutions, Inc.; Burlington (MA); On-site; USD 115,000 - 130,000; Full time

Job summary

BrioHealth Solutions is seeking a Senior Regulatory Affairs Specialist to support the BrioVAD LVAS. This role partners with clinical, R&D, quality, and medical affairs teams to drive regulatory planning, submissions, and lifecycle management.

You will manage FDA submissions, advise on labeling and study documentation, and help navigate EU MDR and CE marking efforts for class III devices. Candidates should bring strong technical writing and project leadership.

Qualifications

• Bachelor’s degree in life sciences, engineering, or related technical field.
• At least five years of medical device regulatory affairs, or three with advanced degree.
• Knowledge of U.S. medical device regulations (21 CFR parts 11, 50, 54, 56, 812, 820).
• Experience preparing FDA submissions (IDE, PMA, supplements, annual reports).
• Knowledge of EU MDR 2017/745, CE marking, GSPR, PMCF, PMS, vigilance, UDI, and EUDAMED.
• Experience with Notified Bodies and CE mark maintenance for Class III devices.
• Familiarity with ISO 13485, ISO 14971 and harmonized standards.
• Experience with clinical studies and cross-functional teams.
• Class III device experience strongly preferred; implantable cardiovascular life-sustaining devices.
• Strong technical writing, communication, and organizational skills.
• Ability to manage competing priorities in a fast-paced environment.

Responsibilities

• Prepare and maintain FDA submissions for the BrioVAD system and the INNOVATE trial.
• Collaborate with Clinical, R&D, Quality, Medical Affairs on regulatory plans.
• Provide regulatory guidance on protocols, informed consent materials, labeling, and study documentation.
• Assess regulatory impact of product, manufacturing, software changes.
• Support FDA communications and meetings with cross-functional input.
• Review documentation for accuracy and submission readiness.
• Monitor US regulations and industry standards and communicate requirements.
• Maintain regulatory records, submission files, approvals and commitments.
• Manage multiple deliverables and identify delays.
• Support EU MDR strategy, CE marking, Notified Body interactions.
• Prepare EU technical documentation and PMCF/PMS materials.
• Support EU clinical/post-market obligations and vigilance inputs.
• Evaluate changes for EU regulatory impact including UDI/EUDAMED.
• Coordinate with Authorized Representative and Notified Body to fulfill commitments.

Skills

Regulatory affairs

Medical devices

Clinical studies

Regulatory writing

Cross-functional collaboration

Project management

Education

Bachelor’s degree in life sciences or engineering

Advanced degree preferred

Job description

Salary Range: $115,000.00 To $130,000.00 Annually

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 enabling chronic MCS therapy to be accessible to more patients across the globe.

The Role

BrioHealth Solutions is seeking a skilled and self-motivated Senior Regulatory Affairs Specialist to support the BrioVAD® Left Ventricular Assist System. This individual will partner with cross-functional teams to support product development activities, US and EU clinical studies and regulatory planning and submission activities.

What You’ll Do

• Prepare, review, and maintain FDA submissions supporting the BrioVAD System and the INNOVATE™ Trial, including IDE submissions, supplements, amendments, and annual reports.
• Partner with Clinical, R&D, Quality, Medical Affairs, and other cross-functional teams to incorporate regulatory requirements into clinical and product development activities.
• Provide regulatory guidance on clinical protocols, informed consent materials, investigator communications, labeling, device changes, and other study-related documentation.
• Assess product, manufacturing, software, labeling, and clinical study changes to determine their regulatory impact and applicable FDA reporting or submission requirements.
• Support FDA communications and meetings by preparing materials, coordinating cross-functional input, and tracking regulatory questions and commitments.
• Review technical, clinical, and quality documentation for accuracy, consistency, and submission readiness.
• Monitor changes to U.S. regulations, FDA guidance, and relevant industry standards; evaluate their impact and communicate applicable requirements to internal stakeholders.
• Maintain accurate regulatory records, submission files, agency correspondence, approvals, and commitments in accordance with internal procedures.
• Manage multiple regulatory deliverables and timelines while proactively identifying and escalating risks or potential delays.
• Support EU MDR regulatory strategy and CE marking activities for the BrioVAD® LVAS, including planning for conformity assessment, Notified Body interactions, and maintenance of EU regulatory deliverables.
• Contribute to preparation, review, and lifecycle maintenance of EU technical documentation, including General Safety and Performance Requirements (GSPR) evidence, clinical evaluation documentation, post-market surveillance inputs, and related submission-ready records.
• Support EU clinical and post-market obligations, including clinical investigation documentation, PMCF planning, vigilance inputs, field safety communications, periodic reporting, and responses to regulatory or Notified Body questions, as applicable.
• Evaluate design, manufacturing, software, labeling, supplier, and clinical study changes for EU regulatory impact, including potential effects on CE marking, technical documentation, GSPR compliance, UDI/EUDAMED data, and Notified Body notification requirements.
• Coordinate with Authorized Representative, importer/distributor, Notified Body, and internal stakeholders to ensure EU regulatory commitments, timelines, and evidence needs are identified, tracked, and fulfilled.

What You Bring

• Bachelor’s degree in life sciences, engineering, or a related technical discipline required; advanced degree preferred.
• At least five years of medical device regulatory affairs experience with a bachelor’s degree, or at least three years with an advanced degree.
• Working knowledge of applicable U.S. medical device regulations, including 21 CFR Parts 11, 50, 54, 56, 812, and 820.
• Experience preparing or supporting FDA medical device submissions, such as IDE or PMA submissions, supplements, amendments, annual reports, and regulatory responses.
• Working knowledge of EU MDR 2017/745 requirements, including CE marking, technical documentation, GSPR, clinical evaluation/PMCF, PMS, vigilance, UDI, and EUDAMED expectations.
• Experience supporting Notified Body submissions or interactions, EU technical documentation, and/or CE mark maintenance for Class III, implantable, active, cardiovascular, or life-sustaining medical devices preferred.
• Familiarity with ISO 13485, ISO 14971, applicable harmonized standards, MDCG guidance, and EU medical device regulatory intelligence processes preferred.
• Experience supporting medical device clinical studies and collaborating with clinical, technical, and quality teams.
• Class III medical device experience strongly preferred; experience with active implantable, cardiovascular, or life-sustaining devices is highly desirable.
• Ability to assess regulatory requirements and implications across product, software, manufacturing, labeling, and clinical study changes.
• Strong technical writing, communication, analytical, and organizational skills.
• Ability to manage competing priorities, exercise sound judgment, and work independently in a fast-paced environment.