- Create, present, and execute regulatory strategies for the company's new breakthroughmedical device products
- Make regular presentations internally and externally to industry and government partners
- Oversee and internally audit the company to global medical device regulations and standardsincluding ISO 13485 and FDA 21 CFR 820
- Act as management representative and coordinate external audits
- Continuously improve the company's SOPs to ensure compliance with changing globalmedical device regulations
- Manage substantial change reporting and advisory notices
- Coordinate with global commercial partners for local regulatory submissions and productclearance
- Engage FDA through pre-submission, breakthrough, and 510(k) applications
- Define and manage design transfer documentation, design history files, and technical filesEducation and Requirements
- Bachelor's degree in engineering, regulatory, quality assurance, or similar
- 4+ years of experience
- Experience and training to MDSAP, ISO 13845, and FDA 21 CFR 820
- Internal and external audit management experience
- Excellent written and verbal communication skills
- Experience leading FDA pre-submissions, breakthrough designation, and 510(k) applications
- Familiarity with medical device reimbursement and its intersection with regulatory strategyRivanna Medical offers the following employee benefits: health insurance, HSA, paid time off, 401(k), team/family events, and more. We are always looking to complement our existing team with individuals that bring unique perspectives and experiences. This variety of thought and perspective drives innovation and strengthens our ability to create an inclusive team environment where our core values of trust, humility, and dedication are practiced every day. As an equal opportunity employer, allapplicants receive consideration for employment without regard to race, color, religion, sex, sexualorientation, gender identity, or national origin.
-
Assistant Dean of Student Affairs
1 week ago
Commonwealth of Virginia Charlottesville, United StatesWe invite applications for an exciting opportunity in the University of Virginia's Division of Student Affairs. The Division of Student Affairs is guided by a three-pronged mission: to help students build community, pursue wellness, and grow as citizen-leaders. We help students d ...
-
Communications Generalist
3 days ago
Commonwealth of Virginia Charlottesville, United StatesIncumbent is responsible for developing and implementing a communications strategy for UVA's Office of Global Affairs and its constituent offices including the International Studies Office, the Center for Global Inquiry and Innovation, the Global Studies Program, and the Center f ...
-
Curriculum Administrator
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe Office of Curriculum in the School of Medicine at the University of Virginia seeks a Curriculum Administrator to complement our existing team. The successful candidate will be highly organized, attentive to detail, self-motivated, and possess the ability to work independently ...
-
Commonwealth of Virginia Charlottesville, United StatesThe University of Virginia seeks applications for an Executive Director of Strategic Communications to join the Office of the Executive Vice President and Chief Operating Officer (EVP-COO). The Executive Director will develop and execute the overall communications strategy for ...
-
Assistant Deans, Housing and Residence Life
1 week ago
Commonwealth of Virginia Charlottesville, United StatesUniversity of Virginia Housing & Residence Life (HRL) is seeking two (2) Assistant Deans for key roles within Residence Life to help meet current challenges, achieve our strategic initiatives, and bring the University's 2030 plan to fruition. Working within a newly expanded staff ...
-
Commonwealth of Virginia Charlottesville, United StatesThe Department of Pediatrics at the University of Virginia (UVA) School of Medicine seeks two candidates to fill our Medical Education Coordinator and/or Assistant positions. The ideal candidate(s) should possess excellent communication and presentation skills, attention to detai ...
-
Assistant Director of Student Life
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe McIntire School of Commerce at the University of Virginia seeks applicants for a new Assistant Director of Student Life (ADSL) to work collaboratively on successfully implementing Student Life functions and educational services. In particular, the ADSL will serve as an acade ...
-
Assistant Director of Transportation
1 week ago
Albemarle County Public Schools Charlottesville, United StatesAssistant Director of Transportation · Albemarle County Public Schools · Department of Transportation · Full-Time, 12 months · Exempt, Pay Grade 20 · VRS-Eligible, Benefits-Eligible · The Assistant Director of Transportation · The Albemarle County Public Schools Department of ...
-
CBO Revenue Cycle Supervisor
1 week ago
State of Virginia Charlottesville, United StatesResponsible for managing the patient financial services functions in the Health System CBO including Billing/Collections; Cash Posting; Contract Management; Customer Service; Judicial Affairs. Oversees one or more of the following functions: inpatient/outpatient billing; cash pos ...
-
Divisional Resource Team Director
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe College and Graduate School of Arts & Sciences (A&S) seeks applicants for a Divisional Resource Team Director to lead a Divisional Resource Team (DRT) that will expand the administrative capacity of the departments in that division and support their success. The DRTs are par ...
-
Assistant Director of Academic Operations
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe McIntire School of Commerce at the University of Virginia seeks applicants for the position of Assistant Director of Academic Operations (ADAO) , a critical member of the Academic Operations team within the School's larger Student Services and Academic Operations unit (SSAO ...
-
Administrative Coordinator
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe Corcoran Department of History at the University of Virginia (UVA) seeks applications for an administrative coordinator. · The University of Virginia's Corcoran Department of History has long been an anchor of the College and Graduate School of Arts & Sciences. Members of the ...
-
Associate Vice Provost for Enrollment
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe University of Virginia (UVA), one of the nation's preeminent public institutions, seeks an experienced, mission-driven, and empathetic leader to serve as Associate Vice Provost for Enrollment and Student Financial Services (AVP SFS). The AVP SFS will join the University and w ...
-
Research Associate in Environmental Sciences
1 week ago
Commonwealth of Virginia Charlottesville, United StatesDepartment of Environmental Sciences invites applicants for a Postdoctoral Research Associate at the University of Virginia, to work on quantifying and predicting forest soil biogeochemical processes that control nutrient and toxic element ecosystem services in forests of the eas ...
-
Commonwealth of Virginia Charlottesville, United StatesThe Environmental Institute (EI) at the University of Virginia (UVA) is seeking a postdoctoral Research Associate to join its Climate Fellows Postdoc Program. The selected candidate will work with an interdisciplinary team of faculty mentors and researchers to realize the goals o ...
-
Director of Development, Karsh Institute
1 week ago
Commonwealth of Virginia Charlottesville, United StatesUniversity of Virginia (UVA) Karsh Institute of Democracy seeks an experienced and accomplished Director of Development. This is an exciting opportunity to create and lead a best-in-class fundraising program as it works towards the highly ambitious goals of the University of Virg ...
-
Divisional Resource Team Finance Manager
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe College and Graduate School of Arts & Sciences (A&S) seeks applicants for a Finance Manager to work closely with one of the A&S divisions as part of a Divisional Resource Team (DRT) that will expand the administrative capacity of the departments in that division and support t ...
-
Director of Development
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe University of Virginia Frank Batten School of Leadership and Public Policy (Batten School) seeks an experienced, creative, and energetic professional to serve as the Director of Development. Acting as a fundraising thought partner with Dean Ian Solomon, the Director will sit ...
-
Assistant Director for Career Development
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe McIntire School of Commerce at the University of Virginia seeks applicants for a newly created Assistant Director for Career Development to join the Commerce Career Services (CCS) team at the McIntire School of Commerce. As a member of a dynamic team committed to providing e ...
-
Medical Science Liaison
2 days ago
Ipsen Biopharmaceuticals, Inc. Charlottesville, United States Full timeTitle:Medical Science Liaison - Neuroscience · Company:Ipsen Biopharmaceuticals Inc. · Job Description: · Medical Science Liaison – Neuroscience · Location: Field Based · Territory: (FL, GA, AL, MS, PR, NC, SC, & TN) · Summary / purpose of the position · Ipsen's Neuroscience Fiel ...
Regulatory Affairs Manager - Charlottesville, United States - EcoMap Technologies, Inc
6 days ago
Description
Additional Information is for members only. Join now to get accessSign in to save items, create lists to share with others, and unlock other features - all for free
Sign up or log in
Regulatory Affairs Manager
RIVANNA is seeking a medical device Regulatory Affairs professional to contribute to our emergingmedical device company's rapid growth. You will work within a talented team of professionals as we
strive to achieve our mission to elevate global standards of care with world-first medical imaging
technology. This is a hands-on multidisciplinary role in which the right candidate will actively manage
and execute different aspects of RIVANNA's pre- and post-market regulatory activities and initiatives.
The position will report directly to the Director of Operations and involves frequent written and verbal
presentations to Federal government officials.
JOB DESCRIPTIONRIVANNA is seeking a medical device Regulatory Affairs professional to contribute to our emergingmedical device company's rapid growth.
You will work within a talented team of professionals as westrive to achieve our mission to elevate global standards of care with world-first medical imagingtechnology.
This is a hands-on multidisciplinary role in which the right candidate will actively manageand execute different aspects of RIVANNA's pre- and post-market regulatory activities and initiatives.
The position will report directly to the Director of Operations and involves frequent written and verbalpresentations to Federal government officials.
ResponsibilitiesRIVANNA operates an FDA-registered and ISO13485:2016 certified manufacturing facility where it produces the Accuro product line and relatedmedical equipment and components.
Accuro is the world's first spinal navigation device designed toimprove the safety, speed and efficiency of spinal needle guidance procedures.
RIVANNA'srevolutionary platforms feature BoneEnhance, Multi-Frequency Image Reconstruction, whichoptimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3DTM AI-Based Spine Recognition, which automates ultrasound image interpretation.
#J-18808-Ljbffr
