Affiliate Consultant - Washington, United States - Vision Achievement

Vision Achievement Washington, United States

6 days ago

Description

Job Description:

Location: Remote

Residency: UK, EU, EEA, Israel: Citizen/permanent resident required

Hiring Company: Oriel STAT A MATRIX (Website)

If you are an expert in medical device quality and regulatory affairs, looking for a long term contract with plenty of opportunity to grow your medical device RA/QA skills and experience, this role may be for you.

Founded in 1968, Oriel STAT A MATRIX is now a business unit of ELIQUENT Life Sciences, a leading global organization providing consulting and training services to the Regulatory Affairs and Quality Assurance functions within the Life Science industry. We are proud of our focus on client outcomes: we achieve superior client results because we select from a pool of highly skilled, specialized, commercially minded Quality System and Regulatory Affairs employees and a set of Affiliate consultants with exceptional skills in specific areas. Together, our team can execute best-in-class advisory, audit, consulting, and training services in the medical device market. We are looking for individuals who possess a level of skills, attributes, and talents commensurate with our brand.

The growing environment for medical/in-vitro device quality and regulatory affairs support services means we are currently seeking to add key experts into our Life Science practices. We are looking for individuals who possess a level of skills and talents commensurate with our brand.

Job Overview

This is a key role and will provide direction to medical device clients, establishing and managing globally compliant quality systems in a number of regulatory environments and auditing to a wide range of standards. Focus will be on US FDA and 510(k) submissions.

Principal Responsibilities

Handle product registrations to accomplish both US and international successes for a wide range of product types within medical devices and in vitro devices.
Conduct establishment, management and remediation of quality management systems commensurate with the target risk of products - particularly under 21 CFR 201/211, 820, 700, MDSAP, EU-MDR and ISO13485.
Lead on the creation and filing of all technical documentation, submission of 510(k)s for the FDA and equivalent filings for EU-MDR.

Job Qualifications/Experience

Bachelor's degree in related field such as (Engineering, Science, Regulatory Affairs or other applicable degree). Masters degree preferred.
Demonstrated experience with EU-MDR, CFR 21 Part 820, ISO 13485; ISO 14971; pre-market, production and post-market aspects of the work; 510(k), CAPA, Technical Files, CE Marking, De Novo
4 - 5 years experience in the medical device industry
Experience working on multi-disciplinary teams with demonstrated evidence to drive change by influencing all levels of the organization
Ability to work in the Hebrew language will be a plus

Travel

There is no regular travel associated with this contract. There may be occasional business trips within Europe or to Israel.

Required Skills:

•21 CFR part 820

•Technical Files

•ISO 14971

•CAPA

•EU MDR

•ISO 13485

•CE marking

•510k

Salary Package:
$ US Dollar)

Organizational Specialist

1 day ago

National Education Association Washington, United States

If you would enjoy working in a dynamic environment and are looking for an opportunity to become part of a stellar team of professionals, we invite you to apply online today. · Posting Period: · September 05, Until Filled · Employee Group Type: · AFSE Association Field Servic ...
Senior Training Lead

2 days ago

Azimuth Washington, United States

Azimuth Corporation is seeking a talented Training Lead to join our NCR team in support of a government customer. The ideal candidate will manage and maintain all courses related to the project through in-person and virtual means. *This position is contingent upon contract award. ...
Deputy Chief Financial Officer

3 days ago

Pailin Group Psc Washington, United States

Deputy Chief Financial Officer — The Pailin Group Professional Search Consultants · THE PAILIN GROUP PROFESSIONAL SEARCH CONSULTANTS · About Us · Job Search · Client Services · Diversity · Candidate Services · Pailin Group Store · Contact Us · October 1, 2020 · Deputy Ch ...
staff assistant

1 day ago

University of the District of Columbia Washington, DC, United States

Number of Vacancies: 1 · Area of Consideration: Open to the Public · Position Status: Full-time, Temporary · Pay Plan, Series & Grade: DS0058/8 · Salary Range: $54,075- $60,292 · Closing Date: Open until filled · Location: 4200 Connecticut Ave. NW. Washington D.C. 20008 · Brief D ...
Regional Sales Executive

6 days ago

GlideFast Consulting Washington, United States

As a Regional Sales Executive with GlideFast Consulting, you will be an integral force in driving the exponential growth of business development and success. You will accomplish this through aggressive identification and qualification of potential customers for ServiceNow product ...
Program Officer III

3 hours ago

Solidarity Center Washington, United States

Job Description · Job Description Salary: · Location: · Washington, DC * · Application Deadline : When filled · * · Please Note : Solidarity Center staff enjoy a hybrid telework/in-person schedule. All candidates applying for this role will be expected to work in the Washingt ...
Records Management Specialist

2 days ago

Evoke Research and Consulting Washington, United States

Evoke Consulting is a Federal Management Consulting firm specializing in strategic business and technology services areas across the federal market. We provide solutions to agencies and entities including Veterans Affairs, Department of Energy, Department of Agriculture, Departme ...
Senior Records Manager

1 day ago

Evoke Research and Consulting Washington, United States

Evoke Consulting is a Federal Management Consulting firm specializing in strategic business and technology services areas across the federal market. We provide solutions to agencies and entities including Veterans Affairs, Department of Energy, Department of Agriculture, Departme ...
US Air Force Strategic Development Manager

20 hours ago

General Atomics and Affiliated Companies Washington, United States

General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. · This position reports to a senior ...
field office manager

1 day ago

Elemy Washington, DC, United States

At Scale is hiring for the 2024 election cycle To apply, respond to this job post. · Pay and Benefits · * Field Office Manager is a full-time salaried-exempt role, paid semi-monthly, at $8,000 / month · * Travel and accommodation expenses covered when relocating for work · * Cell ...
Medical Laboratory Scientist

1 day ago

MedStar Health Washington, United States Part time

General Summary of PositionPerforms a variety of laboratory testing from waived to high complexity per CLIA. Will work in one or more laboratory sections. Evaluates and reports results for use in patient diagnosis and treatment. · Primary Duties and Responsibilities Contributes ...
research assistant/analyst, data science

1 day ago

APCO Worldwide Inc. Washington, DC, United States

APCO Insight, the strategic research consultancy within global communication firm APCO Worldwide, is seeking a Research Assistant/Analyst (Data Science) to join its growing team in Chicago,Raleigh or Washington, D.C. · APCO Insight works with many of the world's leading companies ...
Senior Project Manager

4 days ago

Evoke Research and Consulting Washington, United States

Evoke is seeking a Project Manager to join our team · Evoke Research and Consulting is a federal management consulting firm specializing in management consulting, acquisition consulting, and technology management. We provide solutions to the top federal government agencies and e ...
IT Portfolio Management Specialist

2 days ago

Evoke Research and Consulting Washington, United States

Evoke Consulting is a Federal Management Consulting firm specializing in strategic business and technology services areas across the federal market. We provide solutions to agencies and entities including Veterans Affairs, Department of Energy, Department of Agriculture, Departme ...
Poison Information Specialist

1 day ago

George Washington University Washington, United States Part time

I. JOB OVERVIEW · Job Description Summary: · The National Capital Poison Center, founded in 1980, is an independent, private, not-for-profit organization affiliated with The George Washington University Medical Center. In recognition of its high quality, the Center is accredited ...
FOIA Program Manager

3 days ago

Arcetyp LLC Washington, United States

Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services. We are recruitin ...
Unit Secretary- Float Pool

1 day ago

MedStar Health Washington, United States

General Summary of PositionJoinMedStar Washington Hospital Center as a Per Diem Unit Secretary in the FloatPool department. This opportunity is great for someone who is looking to joinMedStar Health with minimal experience This opportunity allows you to have aflexible schedule wh ...
FOIA Program Manager

4 days ago

Arcetyp LLC Washington, United States

Job Description · Job Description Salary: · Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. · Services include Management & IT Consulting, Program & Project Management, and ...
Financial Analyst(Client Finance)

2 days ago

APCO Worldwide Washington, United States

Job Description · The Financial Analyst is primarily responsible for managing the accounting process and financial aspects for APCO's clients. The Financial Analyst will be tasked with several client billing, revenue recognition, outgoing financial analysis, and budget tracking. ...
Senior Knowledge Analyst

4 days ago

Boston Consulting Group Washington, United States

WHAT YOU'LL DO · As a Senior Knowledge Analyst (SKA) within BCG's Public Sector practice area you will work in a growing global team, providing digital and technology expertise and insights whilst working together with case and proposal teams to provide knowledge assets, analysi ...