Hiring: Senior Regulatory Affairs Specialist Company: EBR Systems, Inc. Location: Santa Clara, CA Job Posted Time: 2026-09-03 14:41:57 Employment Type: On-site Target Skills & Keywords : Risk Management About the job Experience: •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. Required Skills: •Based in Silicon Valley, we're advancing the WiSE System, a first-of-its-kind device in cardiac rhythm management. Your work here has a direct line to patients whose lives depend on what we build. We hire people who want to solve hard problems and who care about getting it right. •We invest in our people as much as our technology. Expect a collaborative, transparent culture, real career growth in a fast-moving startup, competitive compensation, equity, comprehensive benefits, and generous PTO. •If you want your work to matter, EBR is where you belong. •Essential And Other Duties And Responsibilities •Represents RA department in assigned project meetings and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate. •In conjunction with project teams and international partners, evaluates possible pathways to marketing authorization and recommends pathway that appropriately weighs the probability of success with potential risks to the business. Develops and executes sound regulatory strategies to support business goals. •Independently assesses product and manufacturing changes and develops well-justified regulatory assessments for each global market. •Reviews and approves 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 and ongoing sustaining support. Qualifications: •Strong knowledge of US and international medical device regulations. Ability to interpret regulatory requirements and provide actionable guidance to cross-functional team members. •Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills. •Actively works together with formal and informal team members to build relationships and achieve team goals. •Effectively manages multiple assignments and prioritizes work to ensure timely completion of work within scope. •Continuously builds functional and technical expertise and proactively applies that technical expertise in progressively broader scope. •Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility. •Seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately. •Demonstrated capacity to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. •Demonstrated capacity to work in collaborative and independent work situations and environments with minimal supervision. •Willingness and able to travel approximately 10% of the time for on-site/local work arrangement. Travel may include weekends and overnight stay. Compensation: •$115,500 - $156,400 / year •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!