Senior Regulatory Affairs Specialist - Medical Devices

Job Type
Full-time
Description
As a Senior Regulatory Affairs Specialist, you are an experienced and independent professional who will contribute to EBR's mission of receiving US regulatory approvals and maintaining our CE Mark. You will be responsible for performing technical writing for regulatory submissions across all geographies. Be part of the team that ensures that EBR's products meet all the necessary regulatory requirements.
Please note - this is an on-site position in Sunnyvale, CA. Relocation assistance is not available.
What you will do:

• In this role, you will be focused on the regulatory requirements associated with one or more of our product lines.
• Critically review documents (including but not limited to engineering drawings & specification documents), interpret, organize, and summarize results for inclusion in regulatory submissions (PMA and EU MDR).
• Provide technical writing support - ensuring quality of content - with a focus on clarity, grammar, accuracy, and consistency, while maintaining adherence to proper format, regulatory requirements, and company guidelines/styles.
• Collaborate with cross-functional team members to ensure accurate and timely completion/delivery of high-quality, supporting documents
• Provide support to currently marketed products as necessary, including reviewing change requests and assessing regulatory implications.
• Coordinate and work with engineers and technical experts to provide additional data/information requested by regulatory agencies and prepare responses to achieve regulatory approval.
• Maintain an excellent understanding of global medical device regulations regarding the following: AIMDD, ISO 14971, ISO 13485, IEC 62304, IEC 60601 series, MDR 2017/745, FDA QSR 21 CFR Part 820 and others as required.

Requirements
Education & Experience:

• Bachelor's degree in a scientific field, engineering, or related discipline.
• Minimum 6 years of experience in medical device Regulatory Affairs/technical writing.
• 3+ years of related work experience in implantable / cardiovascular Medical Devices products, class III devices desirable.
• Experience with regulatory submissions such as 510(K), PMA or PMA/S, Technical Files, Design Dossiers, Change Notifications, Annual Reports, CERs, PMCF reports, FDA 5-day notices, and IDE Supplements.
• Experience with US, CE, and other international regulations for Medical Devices, including regulatory support for movement of devices across geographies.

Knowledge, Skills, & Abilities:

• Proven ability in technical / medical reading and writing, including the ability to check technical contents for consistency and accuracy.
• Abler to prioritize and execute tasks in a fast-paced environment.
• Ability to work in collaborative and independent work situations and environments with minimal supervision.
• Domestic and international regulatory guidelines, policies, and regulations such as ISO 13485, ISO 14971, IEC 62304, AIMD, MEDDEV 2.12-1 rev 8, Guidelines on a Medical Device Vigilance System, and U.S. Quality System Regulation (21 CFR 820), Design Control knowledge required.
• GxPs (GCPs (Good Clinical Practice), GLPs (Good Laboratory Practice), GMPs (Good Manufacturing Practice)) knowledge.
• Excellent teamwork, communication (written and verbal), attention to detail, and presentation skills.
• Fluency in technical and common office applications.
• Medical device software experience a plus.

Salary Range:
$122,500 - $157,500
Base pay is one part of your total compensation. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, and alignment with market data.
About EBR Systems
Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The company's patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management.
We are a team of dedicated individuals, driven to deliver superior treatment to millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective, and reliable therapies using wireless cardiac stimulation.
As a fast-paced company, every team member at EBR makes important contributions toward our mission. We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring a ground-breaking technology to market.
EBR Systems offers a great place to work as well as generous benefits and growth opportunities:

• Medical, dental, vision, Life, and ADD insurance
• 401K
• PTO - starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• Life insurance
• Weekly company lunches and quarterly happy hour events

Salary Description
$122,500 - $157.500 per year