Senior Regulatory Affairs Specialist

Company: EBR Systems Inc
Location: Sunnyvale
Posted on: June 26, 2022

Job Description:

Description:
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 of 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 a big contribution towards 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. The successful candidate is an experienced Senior Regulatory Affairs Specialist who will contribute to EBR's regulatory mission of receiving US regulatory approvals and maintaining CE Mark. This role will be responsible for performing technical writing for regulatory submissions across all geographies.

• 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
• Support regulatory submissions by authoring and/or editing regulatory submissions.
• Provide support to currently marketed products as necessary including reviewing change requests and assess regulatory implications.
• Coordinate and work engineers and technical experts to provide additional data/information requested by regulatory agencies and prepare responses to achieve regulatory approval.
• Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.
• Maintain an excellent understanding of global medical device regulations regarding the following: AIMDD, MEDDEV 2.12-1 rev 8, Guidelines on a Medical Device Vigilance System, ISO 14971, ISO 13485, EN 62304, MDR 2017/745, FDA QSR 21 CFR Part 820 and others as required.
• Maintain RA SOPs and provide editorial or review support for other QMS documents. EBR Systems offers a great place to work as well as generous benefits and growth opportunities:
  • Medical, dental, and vision insurance
  • 401K
  • PTO
  • Competitive salary with opportunities for career growth
  • Employee stock options
  • 401(k) Bonus Program
  • Life insurance 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. Qualifications:
      • Fluency in technical and common office applications.
      • Proficient in technical / medical reading and writing.
      • Ability to prioritize and execute tasks in a fast-paced environment
      • Ability to work in collaborative and independent work situations and environments with minimal supervision.
      • Excellent teamwork, communication (written and verbal), attention to detail, and presentation skills.
      • Ability to check technical contents for consistency and accuracy
      • 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, GLPs, GMPs) knowledge.
      • Medical device software experience a plus. PI182625491

Keywords: EBR Systems Inc, Sunnyvale , Senior Regulatory Affairs Specialist, Other , Sunnyvale, California