Description
The Regulatory Affairs Specialist or Senior Specialist leads the post-approval regulatory activities related to manufacturing and design changes. This position collaborates with Manufacturing, Quality, Supply Chain, and Sustaining Engineering to ensure regulatory compliance and global market access. The position is responsible for preparing sustaining regulatory documentation, and ensuring activities align with applicable regulatory requirements.
Why this role matters now:
With premarket approval secured and launch in progress, our ability to execute sustaining engineering changes, support manufacturing scale-up, and maintain compliant product availability is essential. This role supports continuity, efficiency, and compliance across the lifecycle of a novel Class III therapy.
Essential duties and responsibilities include, but are not limited to, the following:
- Serve as the first-line regulatory contact for change orders, line support, and sustaining initiatives across Operations, Quality, and Engineering.
- Execute regulatory strategies for post-market product changes, balancing compliance with business objectives.
- Preparation and submission of PMA supplements, 30-day notices, annual reports, and global regulatory filings.
- Prepare and manage regulatory presubmissions for post-approval changes to engage proactively with FDA and other regulatory authorities.
- Review and approve change documentation, including engineering change orders, risk assessments, labeling, and supporting test data.
- Interpret global regulatory requirements and standards (e.g., FDA, EU MDR, TGA, MHRA, ISO 13485, IEC 60601, IEC 62304, RoHS) and apply them across sustaining activities.
- Support audit readiness, regulatory inspections, and quality system improvements tied to sustaining projects.
- Provide regulatory guidance to cross-functional teams on design and manufacturing changes, field actions, and remediation efforts.
- Coordinate lifecycle regulatory strategy with New Product Development (NPD) RA leads to ensure consistent oversight and alignment
- Collaborate cross-functionally to maintain regulatory compliance throughout the product lifecycle
- Monitor evolving global regulations and assess their impact on product portfolio and internal procedures.
- Contribute to process improvement and knowledge management initiatives within the Regulatory function.
- Other duties as assigned.
Education and Required Experience:
Regulatory Affairs Specialist
- Bachelor's degree in a scientific, engineering, or technical discipline is required.
- Advanced degree (e.g., M.S.) is preferred but not required.
- 0-2 years of experience in regulatory affairs, preferably in the medical device industry.
Senior Regulatory Affairs Specialist
- Bachelor's degree in a scientific, engineering, or technical discipline is required.
- Advanced degree (e.g., M.S., Ph.D.) is strongly preferred and may substitute for 1–2 years of experience.
- Minimum of 5 years of regulatory affairs experience, including post-market and sustaining activities.
- International experience in class II or IV medical devices is a plus.
Knowledge, Skills, and Abilities:
Regulatory Affairs Specialist
- Basic understanding of U.S. FDA and international regulatory requirements.
- Experience supporting regulatory submissions under supervision.
- Strong written and verbal communication skills, attention to detail, and the ability to work collaboratively in a cross-functional team.
- Works under guidance and seeks mentorship to develop regulatory expertise.
- Regulatory Affairs Certificate is a plus.
Senior Regulatory Affairs Specialist
- In-depth knowledge of global post-market regulatory frameworks (e.g., PMA, EU MDR, TGA).
- Demonstrated success in independently preparing and leading regulatory submissions.
- Strong leadership, strategic thinking, and cross-functional communication skills.
- Capable of working independently and serving as a subject matter expert for sustaining regulatory affairs.
Physical Requirements:
- Willingness and able to travel approximately 10% of the time. Travel may include weekends and overnight stay.
- Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms. Required to stoop, kneel, bend, crouch and lift up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.
- Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels.
EBR Systems, Inc. is an Equal Opportunity Employer committed to a diverse, inclusive, and equitable workplace.
Salary Range:
Regulatory Affairs Specialist: $90,600 - $116,400*
Senior Regulatory Affairs Specialist: $117,700 - $151,300*
*Base pay is one part of your total compensation. The salary offered will depend on several factors, including, but not limited to your experience, knowledge, skills, location, internal equity, and market alignment. Addition compensation may include bonuses and equity, along with a comprehensive benefits package.
EBR Systems, Inc. is an Equal Opportunity Employer committed to a diverse, inclusive, and equitable workplace.
EBR Systems, Inc. does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please refrain from solicitations at this time.
About the Company:
What if your work doesn’t just support innovation—what if it changes lives? At EBR Systems, Inc., we are not imagining that future—we are building it. We are the team behind the world’s first FDA approved, leadless left ventricular endocardial pacing device for heart failure. It’s a breakthrough redefining what’s possible in heart care, and it’s just the beginning!
We don’t just create game-changing medical devices—we grow people. Patients come first in everything we do. You will be empowered to solve real problems and to do meaningful work that truly makes a difference. If you are driven by purpose, excited by challenge, and ready to shape the future of cardiac technology, we want to hear from you. Visit us at https://www.ebrsystemsinc.com/ to learn more—and join us in our work Empowering Physicians, Powering Hearts.
EBR Systems offers a great place to work as well as generous benefits and growth opportunities:
- Medical, dental, and vision insurance provided at no cost for employee-only coverage
- 401(k) matching plan
- Paid Time Off – starting at 3 weeks per year
- Competitive salary with opportunities for career growth
- Employee stock options
- Life & AD&D and long term disability insurance
- Education assistance
- Voluntary commuter benefits and pet insurance
- Weekly company lunches and occasional happy hour events
- Meaningful work and much more!
This is a unique opportunity to shape the future of a first-in-class therapy and help lead EBR Systems, Inc. through its most exciting phase yet. If you're ready to step into a high-impact role at the center of regulatory, operations, and commercial execution—we want to hear from you.
