Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist

Job Description

BrioHealth Solutions Inc., Inc. is seeking a skilled and self-motivated Principal Regulatory Affairs Specialist to join our growing team. As a principal regulatory affairs specialist at BrioHealth Solutions Inc., you ll support product development activities for Class III Medical Devices and have responsibility for preparing and submitting submissions to global regulatory authorities.

Responsibilities

Work with cross-functional teams to provide regulatory guidance during the development of Class III Medical Devices

Establish the regulatory strategy and global registration plan for products, meeting internal quality system requirements and product development process expectations

Prepare regulatory submissions, including applications for Investigational Device Exemption and Premarket Approval for the US market and clinical trial applications anddesign dossiers for EU market

Communicate directly with regulatory reviewers (FDA, Notified Body, Competent Authority, etc.) and work with internal cross-functional teams to address

Support regulatory intelligence efforts by monitoring for new or changed global regulations and guidance documents and new or revised industry standards, assessing forimpact and communicating among the organization

Provide regulatory support for clinical and post-market activities including adverse event reporting, labeling updates and regulatory inquiries

Requirements

Bachelor s degree required, science or technical are preferred

Minimum of 7 years regulatory affairs experience required with Bachelor's degree

Minimum of 5 years regulatory affairs experience with Advanced degree

Experience of working within the requirements of 21 CFR 820, ISO 13485, the MedicalDevices Directive (93/42/EEC) and European Medical Device Regulation 2017/745

Class III Medical Device experience preferred (IDE, PMA, Active Implantable)

Experience with SaMD and experience with medical device software requirements and software regulations preferred

Ability to effectively manage multiple projects and priorities

Experience working with cross-functional teams

Excellent written and verbal communication skills

Strong Organizational skills and attention to detail

Self-motivated and able to work independently

About BrioHealth Solutions Inc.

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.