Senior Regulatory Affairs Specialist
Company: EBR Systems Inc
Posted on: June 24, 2022
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
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
Support regulatory submissions by authoring and/or editing
Provide support to currently marketed products as necessary
including reviewing change requests and assess regulatory
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
Maintain RA SOPs and provide editorial or review support for other
EBR Systems offers a great place to work as well as generous
benefits and growth opportunities:
Medical, dental, and vision insurance
Competitive salary with opportunities for career growth
Employee stock options
401(k) Bonus Program
Education & Experience:
Bachelor's degree in a scientific field, engineering, or related
Minimum 6 years of experience in medical device regulatory
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
Experience with US, CE, and other international regulations for
medical devices, including regulatory support for movement of
devices across geographies.
Fluency in technical and common office applications.
Proficient in technical / medical reading and writing.
Ability to prioritize and execute tasks in a fast-paced
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
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
GxPs (GCPs, GLPs, GMPs) knowledge.
Medical device software experience a plus.
Keywords: EBR Systems Inc, Sunnyvale , Senior Regulatory Affairs Specialist, Other , Sunnyvale, California
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