Senior Regulatory Affairs Specialist
Company: EBR Systems Inc
Location: Sunnyvale
Posted on: June 24, 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. PI182625511
Keywords: EBR Systems Inc, Sunnyvale , Senior Regulatory Affairs Specialist, Other , Sunnyvale, California
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