Senior Regulatory Affairs Specialist
Company: EBR Systems Inc
Location: Sunnyvale
Posted on: June 20, 2022
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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 documentsSupport 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
insurance401KPTOCompetitive salary with opportunities for career
growthEmployee stock options401(k) Bonus ProgramLife 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
environmentAbility 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 accuracyDomestic 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.
PI182625625
Keywords: EBR Systems Inc, Sunnyvale , Senior Regulatory Affairs Specialist, Other , Sunnyvale, California
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