Senior Regulatory Affairs Specialist

BRIOHEALTH SOLUTIONS INC•Burlington, MA

2d•$115,000 - $130,000

About The Position

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.

Requirements

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 medical device clinical studies and collaborating with clinical, technical, and quality teams.
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.

Nice To Haves

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.
Class III medical device experience strongly preferred; experience with active implantable, cardiovascular, or life-sustaining devices is highly desirable.

Responsibilities

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.