Job Responsibilities
- Support frequent mior software releases by performing change assessments
- Support EU MDR application and maintenance of technical documentation, including clinical evaluation
- Collaborate with cross-functional teams to drive regulatory project management activities
- Manage timely completion of new product registrations and maintain global regulatory approvals to market software devices
- Collaborate with external partners including regulatory agencies, authorized representatives, importers and distributors
- Gain experience with US FDA submissions
- Provide input to the risk management process to ensure risks are identified and updated during the product life-cycle
- Conduct regulatory surveillance and communicate changes in regulations., standards, and guidances
- Support Quality System management, as needed
- Other relevant duties as assigned
- Ability to work in a fast-paced adaptive environment, self-starter, and strong team player
Skills Needed :
- Base knowledge of global regulatory requirements
- Project management skills a plus
- Demonstrated team collaboration
- Excellent communication, writing, and editing skills
- Strong Word, Excel, and PowerPoint skills
Educational Requirements & Work Experience :
- Bachelor’s degree
- 1-3 years of experience in Regulatory Affairs
- Software medical device experience a plus
This position has an estimated base salary of $90,000 - $105,000, a cash bonus and stock options. HeartFlow is a mature start-up, pre-ipo market place leader, changing the paradigm in Coronary Artery Disease Diagnostics.
HeartFlow, Inc. is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
This policy applies to every aspect of employment at HeartFlow, including recruitment, hiring, training, relocation, promotion, and termination.
Positions posted for HeartFlow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.
Managing Consultant, Environmental Regulatory Specialist (Senior Level)
Environmental Regulatory Specialist. For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 - $94,860 (USD). Federal Energy Regulatory Commission (FERC). Research, analyze and compile data for permit applications and rep...
Senior AWS Compliance Specialist, Regulatory Assurance
At AWS' scale, we must invent new ways to provide the highest level of assurance to our most regulatory conscious customers. We are looking for a highly motivated Senior regulatory expert to join our team. This role facilitates our ability to grow and scale our internal compliance processes to meet ...
Managing Consultant, Environmental Regulatory Specialist (Senior Level)
Environmental Regulatory Specialist. For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 – $94,860 (USD). Federal Energy Regulatory Commission (FERC). Research, analyze and compile data for permit applications and rep...
Regulatory Affairs Specialist (Austin, TX)
The Regulatory Affairs Specialist is responsible for supporting the development and implementation of the overall objectives and regulatory strategies that impact the introduction of new products, and the market status of existing products. The Regulatory Affairs Specialist I will assist Regulatory ...
Regulatory Affairs Specialist
The Regulatory Affairs Specialist will be the regulatory representative on product development teams and will be responsible for developing regulatory strategies, authoring submissions, and assessing design and manufacturing changes for wide range implantable products. Works with regulatory and cros...
Regulatory Specialist
Collaborate with cross-functional teams to drive regulatory project management activities. Manage timely completion of new product registrations and maintain global regulatory approvals to market software devices. Collaborate with external partners including regulatory agencies, authorized represent...
Principal Biologist/Regulatory Specialist (Principal Level)
ERM has an opportunity for an experienced biologist/regulatory specialist to join our thriving global consulting firm as a . Principal Biologist/Regulatory Specialist. Principal Biologist/Regulatory Specialist. Serve as Project Biologist/Regulatory Specialist for environmental impact assessment unde...
Mechanical Engineer Project Manager III (PM3)
Project Management Professional (PMP) or Certified Energy Manager(CEM) , or other similar demonstration of formal project management training. Mechanical Engineer Project Manager III (PM3). The University of Texas at Austin is seeking to hire a Mechanical Engineer Project Manager III (PM3) holding a...
Healthcare Regulatory Associate
A global and top 200 Am Law firm seeks an associate to join their Healthcare Team in their Austin office. The ideal candidate must have 3-5 years of experience to work on healthcare regulatory compliance and policy matters in the areas of life sciences and technology. Ideal candidates will have demo...
Associate Attorney - Projects (Regulatory)
Our client, a prestigious Am Law 100 firm, is seeking an Associate Attorney to join their projects team! This team is recognized as Band 1 in all relevant categories by Chambers. Address regulatory aspects of developing, financing, buying, and selling a diverse range of energy projects across the co...