Jobs in the United States

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Added 3 mins ago
Process Operator - Level 2
Swagelok Company
Highland Heights
…recognition of routine problems and the ability to keep the process running by making appropriate adjustments to correct the…
Added 3 mins ago
Task Coordinator III
KCI Technologies Inc.
Wilmington, NC
KCI Technologies, Inc. is a 100% employee-owned engineering, consulting and construction firm serving clients throughout the United States. KCI is recognized as an industry leader,…
Added 4 mins ago
SI
Critical Facilities Engineering Manager
Salute Inc.
Afton, TX
- $125,000 to $140,000 USD / year
…we are seeking a dynamic and experienced Critical Facilities Engineering Manager to join our team and drive our relationships with hyperscale clients to new…
Added 8 mins ago
Bridge Engineer
HNTB Corporation
Salt Lake City, UT · Denver, CO
…and modification of design calculations, technical reports, engineering plans and specifications for assigned projects. This position works closely with the project manager to perform…
Added 12 mins ago
Project Coordinator, Grid Strategy & Solutions
Southern Company
Atlanta, GA
…within Grid Strategy & Solutions. Reporting to the Project Manager for federal funding, this position supports the project managers and technical leads on the team while owning…
Added 13 mins ago
Energy Solutions Technical Project Manager (Intermediate or Senior)(Richmond, Hybrid)
Dominion Energy
RICHMOND, VA
…all applicable laws and codes. Ensure vendor compliance with Engineering, Procurement, and Construction (EPC) and Operations and Maintenance (O&M) contracts. Provides technical project…
Added 20 mins ago
BO
SUPERVISORY CIVIL ENGINEER
Bureau of Reclamation
Lakewood, CO
- $140,239 to $182,316 USD / year
-Civil Engineering: Knowledge of the concepts, principles, theories, and methods required to prepare analyses, designs, drawings, proposals, scopes of work, specifications, and cost…
Added 20 mins ago
BO
SUPERVISORY CIVIL ENGINEER
Bureau of Reclamation
Lakewood, CO
- $140,239 to $182,316 USD / year
-Uses Civil Engineering knowledge of the concepts, principles, theories, and methods required to coordinate, prepare and review specifications for a variety of heavy-civil and power…
Added 21 mins ago
Hardware Integration Engineer
NCR VOYIX
ATLANTA, GA
Organization: Hardware and Lifecycle Engineering
Added 21 mins ago
Engineering Manager, Order Platform Checkout
DoorDash USA
NY
DoorDash is looking for an Engineering Manager with a strong platform mindset to lead the Order Platform Checkout team. This team’s mission is to deliver reliable, feature-rich, and…
Added 23 mins ago
UA
Program Manager
U.S. Army Corps of Engineers
Chattanooga, TN · Nashville, TN · Grand Rivers, KY · Florence, AL
- $106,437 to $144,102 USD / year
Serve as Deputy Operations Manager for a large, diverse staff to include subordinates, engineering and technicians, administrative staff, skilled trades, program analysts, and contractors.…
Added 23 mins ago
VH
Safety & Occupational Health Manager
Veterans Health Administration
Las Vegas, NV
- $108,719 to $141,337 USD / year
The Safety Manager interacts with the facility Office of Quality Management (which includes quality assurance, utilization management and risk management) headed by the medical center's…
Added 23 mins ago
VH
Housing Manager
Veterans Health Administration
Tucson, AZ
- $91,205 to $118,569 USD / year
…within walking distance of the treatment facility. The Housing Manager serves as supervisor of the Fisher House…
Added 23 mins ago
VH
Healthcare Engineer - Project Engineer
Veterans Health Administration
Seattle, WA
- $62,504 to $141,154 USD / year
The position supports and advances patient care by applying engineering and managerial skills to healthcare engineering as demonstrated by the following major responsibilities:
Added 23 mins ago
VH
Healthcare Engineer - Project Engineer
Veterans Health Administration
Seattle, WA
- $62,504 to $141,154 USD / year
The position supports and advances patient care by applying engineering and managerial skills to healthcare engineering as demonstrated by the following major responsibilities:
Added 25 mins ago
🌎 Hardware Expert (MSc. or PhD), Remote- Contract
Xperteez Technology
Remote, United States
In this role, you will use your technical expertise to create, solve, and evaluate engineering challenges that require sound judgment, quantitative reasoning, and reproducible answers.
Added 26 mins ago
VH
Healthcare Engineer
Veterans Health Administration
Tomah, WI
- $50,460 to $116,362 USD / year
Education: (1) Bachelor's degree or higher in Engineering or Architecture. To be acceptable, the curriculum must be from a school with at least one curriculum accredited by the…
Added 26 mins ago
AN
SURFACE MAINTENANCE MECHANIC
Army National Guard Units
Colchester, VT
- $29 to $39 USD / hour
Added 27 mins ago
Quality Systems Associate Specialist - North Chicago, IL
Military Spouse Jobs & VetJobs
United States
…Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance…
Added 29 mins ago
Service Engineer I
Accelleron US Inc.
USA: Deer Park, TX
Location: Deer Park, TX (Travel Required) | Department: Service Operations | Reports To: Workshop Manager
Added 29 mins ago
AN
SURFACE MAINTENANCE MECHANIC
Army National Guard Units
Jericho, VT
- $29 to $39 USD / hour
Added 29 mins ago
OA
Supervisory Systems Accountant
Other Agencies and Independent Organizations
Charleston, SC
- $125,776 to $163,514 USD / year
…in accounting, auditing, or a related field, e.g., valuation engineering or financial institution examining; (b) a panel of at least two higher level professional accountants or auditors…
Added 29 mins ago
Quality Engineer
Enterprise Precast Concrete
Omaha, NE
…consultation. The Quality Engineer will report to the Quality Control Manager within the Operations…
Added 31 mins ago
G
Project Manager - Earthwork
GPAC
Dublin, OH
- $90,000 to $150,000 USD / year
We are seeking an experienced Project Manager in the Columbus area to oversee large-scale earthwork and site development projects. The ideal candidate will bring a strong background in…
Added 34 mins ago
BO
Civil Engineer
Bureau of Reclamation
Lakewood, CO
- $140,239 to $182,316 USD / year
Oversee the technical application of risk analyses and the development of technical, scientific, economic, and engineering guidelines and studies related to the evaluation, analyses,…

Open Scientific

Regulatory Manager

Sunrise, FL, United States

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Job details

Education: Bachelor’s degree
Experience: Minimum 5 years direct experience in regulatory affairs (preferably in the medical device/drug or biomedical area).
Posting language: English
Posted: Jan 24, 2017

Original job description

Company Description Open Scientific provides contract staffing and direct hire recruitment services for the scientific, engineering, laboratory and manufacturing sectors.

Job Description

Position Summary Manages the regulatory side of the company business to ensure timely product approvals and compliance with domestic and international regulatory requirements

Key Accountabilities:

· Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements, IDE/PMA Annual Progress Reports, 510(k)s, MAFs) · Develop Design Dossiers and Technical Files for CE marking purposes · Develop other international regulatory submissions as required · Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations. · Review, edit and provide regulatory and quality system approval for project documentation. · Review and analyze technical protocols, data, and reports generated by Research and Development, Operations, Clinical Research, Quality Assurance or other related departments. · Participate in the development of world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products. · Partner with cross functional teams by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and compliance activities. · Develop procedures to ensure regulatory compliance · Act as an active regulatory representative on project teams · Respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates. · Review and provide regulatory authorization for Nonconformance reports (NCR) · Provide Regulatory Affairs support during internal and external audits. · Prepare and file facility registration documents · Conduct external audit activities as requested · Prepare the necessary documents to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA · Manage commercial device tracking · Develop clinical protocols and clinical study reports · Prepare and submit medical device reports · Perform various other duties as assigned

Internal Networking/Key relationships:

This position requires cooperating with different company departments, such as R&D, Sales, Logistics, Finance and the other team members of the department.

Minimum Skills and Capabilities:

· Excellent interpersonal skills to interface with project team members and able to contribute to the overall success of the team. · Excellent written, verbal communication and presentation skills are required. · Excellent attention to detail and ability to coordinate multiple activities simultaneously · Excellent computer skills including expertise in Microsoft Office Products, in addition to, Lotus Notes.

Minimum Knowledge & Experience required for the position:

· Bachelor's degree in Science or Engineering (or related field) from an accredited college or university required. Minimum 5 years direct experience in regulatory affairs (preferably in the medical device/drug or biomedical area). · Solid knowledge of US and European regulatory processes, including Class III is required. · Practical (hands-on) experience in a medical device regulatory environment, preparing submissions (IDEs/IDE supplements, PMAs/PMA Supplements, 510(k)s and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record is required. · Experience interacting with U.S. FDA and European Notified Bodies is required. · Experience presenting at FDA meetings is preferred. · Sound knowledge and understanding of how IDE-regulated clinical studies are performed is required. · Experience in review and approval of promotional review process strongly preferred · Comprehensive Knowledge of Design Control processes and controls · Comprehensive Knowledge of Regulatory Standards needed in the medical device environment. Travel requirements: Minimal Additional Information All your information will be kept confidential according to EEO guidelines.

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More about this job

Skills

Regulatory compliance
IDE
Packaging
Documentation
Research
Clinical research
Quality assurance
Strategic planning
Regulatory affairs
Sales
Logistics
Interpersonal skills
Communication skills
Presentation skills
Attention to detail
Computer skills
Microsoft Office
IBM Lotus Notes
Medical devices

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