Regulatory Affairs Manager

Austin, TX  (On-site)       ·      Full time

Please attach Cover Letter with Resume.

The Regulatory Affairs Manager will be responsible for the development of regulatory strategies and interpretation of applicable guidance documents and standards related to active implantable medical devices, neural implants, and brain-computer interfaces. This role will also be responsible for managing the regulatory requirements of medical device software (for both implanted devices and external systems) and supporting the software development teams and software life cycle processes. This role will work cross-functionally and collaborate closely with Quality, Hardware Engineering, Electrical Engineering, Software Development, and the Clinical/Neuro teams. The RA Manager will prepare FDA submissions and interact directly with FDA in support of Q-Sub, IDE, and PMA filings. This position is instrumental in supporting the company’s continued growth and future success, and requires an individual with a “can-do,” self-starter attitude who is excited about working collaboratively and diving into hands-on, detailed regulatory affairs work. This position is based on-site in Austin, Texas and will have less than 5% travel.

Responsibilities include:

• Lead the development and implementation of regulatory strategies including interpretation of applicable guidance documents and standards related to active implantable medical devices, neural implants, and brain-computer interfaces.
• Address software and cybersecurity requirements into regulatory strategies and the related design and development plans, working closely with the Quality and Software Development teams during the planning and execution phases. This role will be the internal regulatory affairs software and cybersecurity subject matter expert.
• Function as a core team member on both software and hardware components, including active implantable devices and non-implantable system components, to support the design control process, test planning/execution, and documentation. This will also include supporting change control and change impact assessments.
• Prepare and submit filings to the US FDA including Q-Subs, IDE, PMA, and other associated FDA interactions. This role will lead the strategy and execution of FDA meetings and communications.
• Provide regulatory input and guidance on the clinical use and clinical trial strategies.
• Develop regulatory strategy and plans for product approvals outside the US.
• Creation of SOPs, work instructions, and other regulatory affairs quality system elements, including development of best practices and workflows to efficiently manage the work.
• Effectively communicate regulatory requirements and strategies across the organization, from the core project team level to senior management.
• Participate in internal and external audits.
• Manage internal regulatory affairs training needs, both internally to regulatory affairs and externally, specifically including Quality, Hardware Engineering, Electrical Engineering, and Software Development.

Required Qualifications

• Bachelor’s degree in an Engineering, Science, or technical field
• 5+ years of Regulatory Affairs experience in medical devices including active implantable devices, neural implants, and/or brain-computer interfaces.
• Experience with medical device quality standards and regulations relating to active implantable devices and medical device software. Recent experiences and real-time knowledge of FDA guidance and other applicable standards is highly desired.
• Experience as a core team member with hands-on responsibilities developing and implementing regulatory strategies.
• Successful history creating FDA submissions and managing the FDA review process with substantial experience interacting directly with FDA. This includes software and cybersecurity FDA submission experiences.
• Successful history developing and executing regulatory strategies outside the US.
• The desire to develop creative solutions to complex problems that meet regulatory requirements and business needs, while sharing knowledge and building consensus amongst stakeholders.
• The desire to thrive in a team environment with a diverse group of people, where individual contributions are highly valued.
• The desire for continuous learning and improvement.
• Excellent communication skills both orally and in written form with a desire for in-person communication. This includes experience leading meetings, projects, and presentations to small and large audiences.
• Excellent organization skills and the ability to manage competing priorities and plan accordingly.
• Proficient skills in statistical data analysis.
• Proficient skills with Microsoft Office Suite, Google G-Suite and other PC based systems.

Preferred Qualifications

• Advanced degree(s) in Engineering or Science with research experience applicable to active implantable devices, neural implants, and/or brain-computer interfaces.
• Experience working directly in the brain-computer interface space or deep brain stimulation.
• Certification(s) in a regulatory affairs discipline such as RAPS/RAC.

Paradromics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

Please click here to apply.