Senior Regulatory Affairs Lead — Med-Tech Heart Devices

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

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.