Principal Regulatory Affairs Specialist

2 weeks ago

Boston, United States BRIOHEALTH SOLUTIONS INC Full time
Job DescriptionJob Description

Principal Regulatory Affairs Specialist

Job DescriptionBrioHealth 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 and design 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 for impact 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 Medical Devices 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.

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