Senior Regulatory Affairs Specialist

About the role

EBR Systems is advancing the WiSE System, the world’s first FDA-approved leadless left ventricular endocardial pacing device for heart failure. As the Senior Regulatory Affairs Specialist, you will represent the Regulatory Affairs department on project teams, develop and execute regulatory strategies, and ensure compliance with global medical device regulations to bring life-saving technology to market.

Responsibilities

• Represent the RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements.
• Evaluate possible pathways to marketing authorization in conjunction with project teams and international partners, balancing probability of success with business risk.
• Develop and execute sound regulatory strategies to support business goals.
• Independently assess product and manufacturing changes and prepare well-justified regulatory assessments for each global market.
• Review and approve document change orders, advertising and promotional material, technical documents, test protocols and reports, risk management documents, labeling documents, and other documents as a key member of assigned project teams.
• Interact with regulatory bodies in the US and internationally to keep projects on track and resolve issues expediently.
• Develop, prepare, and submit high-quality technical documentation and regulatory submissions for approval in the US and other international regions.
• Develop timelines, manage sub-team meetings, and ensure timely execution of regulatory processes.
• Prepare reports for management and develop metrics and proposals for regulatory process improvements.
• Represent the Regulatory Affairs function in internal and external audits and serve as a regulatory subject matter expert.
• Proactively maintain up-to-date knowledge of domestic and international regulatory requirements and communicate them effectively to project teams and management.
• Update departmental procedures as required.

Qualifications

• Bachelor’s degree in a scientific, engineering, or technical discipline.
• Minimum 4 years of directly relevant Regulatory Affairs experience within the Class III medical device industry.
• Strong critical thinking and communication skills with the ability to clearly convey regulatory guidance to cross-functional stakeholders.
• Experience assessing post-market product or process changes.

Knowledge, Skills, and Abilities

• Strong knowledge of US and international medical device regulations.
• Ability to interpret regulatory requirements and provide actionable guidance to cross-functional team members.
• Experience with successful submissions and strategic planning.
• Effective communication across all mediums; ability to present well to groups, actively listen, and continuously improve communication skills.
• Collaborative mindset; builds relationships and achieves team goals.
• Strong prioritization and ability to manage multiple assignments to ensure timely completion.
• Proactive in building functional and technical expertise and applying it broadly.
• Results-focused with initiative; takes ownership, builds relationships, and works across departments.
• Understands diverse perspectives and interpersonal needs; flexes personal style appropriately and works through conflicts constructively.
• Ability to solve practical problems and deal with varied concrete variables in non-standardized environments.
• Ability to interpret instructions in written, oral, diagram, or schedule form.
• Ability to work collaboratively and independently with minimal supervision.

Physical Requirements

• Willingness and ability to travel approximately 10% of the time for on-site/local work arrangements; travel may include weekends and overnight stays.
• Ability to stand, walk, sit, talk or hear, use hands to finger/handle/feel objects or controls, and reach with hands and arms.
• Ability to stoop, kneel, bend, crouch, and lift up to 20 pounds.
• Specific vision abilities include close vision, distance vision, depth perception, color vision, and focus adjustment.
• Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels.

Pay

Base salary range: $115,500 – $156,400. Total compensation may include bonuses, equity, and a comprehensive benefits package. Actual pay will depend on experience, skills, location, internal equity, and market alignment.

Benefits

• 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.
• Employee stock options.
• Life & AD&D and long-term disability insurance.
• Education assistance.
• Voluntary commuter benefits and pet insurance.