Regulatory Affairs Specialist - Washington, United States - Kaztronix

Kaztronix Washington, United States

1 week ago

Description

The Regulatory Affairs Specialist is responsible for working as part of project teams with product development and manufacturing management to ensure that the product development process meets all applicable regulatory requirements.

Responsible for the approval of labeling, marketing literature and finished good specifications.

Responsibilities

Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Utilize this understanding to develop clear procedures for the organization.

Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.

Act as a liaison between their organization and state, local, federal, and international agencies. Including communicate on pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

Participate as a member of project teams to ensure Design Control, Risk Management, and Release to Market activities are in compliance with appropriate standards/regulations

Coordinate, prepare and review documentation for international and domestic submissions for to FDA, Health Canada and other international regulatory agencies.

Strategically achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, technology, compliance, and costs.

Responsible for supporting project teams on various subjects, including export and labeling requirements, premarket regulatory requirements, and clinical study compliance issues.

Review labeling, and finished good specifications, as well as, marketing literature.

Assist on special projects and perform additional duties as assigned

Qualifications

Bachelor's degree in science or a related field

3+ years' experience within Regulatory Affairs

Ability to work on project teams.

Strong communication, organizational and time management skills. Technical writing skills.

Proficient in Microsoft Office

Experience with RIMS (Regulatory Information Management Systems) - preferred

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
#J-18808-Ljbffr

Regulatory Affairs Specialist

1 week ago

Courseadvisor Washington, United States

What Do Regulatory Affairs Specialist Do? · Job Description: · Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies. · Life As a R ...
Government Affairs Specialist

1 week ago

LKQ Corporation Washington, United States

Support Government Affairs Department representing the company's best interest through grassroots initiatives, interacting with state and federal industry associations, and supporting all government relations functions. Essential Job Duties: Execute Government, Specialist, Manufa ...
Regulatory Affairs Specialist

1 day ago

Kaztronix Washington, United States

The Regulatory Affairs Specialist is responsible for working as part of project teams with product development and manufacturing management to ensure that the product development process meets all applicable regulatory requirements. Responsible for the approval of labeling, marke ...
Congressional Affairs Specialist

1 day ago

Goldbelt Incorporated Washington, United States

Overview · Goldbelt C6 offers research and development, engineering, and logistics services that enhance and enlarge customers' operations. C6's expertise is focused on integrating C6ISR and scientific, engineering, and technical support for various government partners. The expe ...
Congressional Affairs Specialist

1 day ago

Goldbelt Washington, United States

Goldbelt C6 offers research and development, engineering, and logistics services that enhance and enlarge customers' operations. C6's expertise is focused on integrating C6ISR and scientific, engineering, and technical support for various government partners. The experts at C6 ar ...
International Affairs Specialist

1 day ago

Deltasands Washington, United States

Delta Solutions & Strategies is seeking a International Affairs Specialist to support The Headquarters United States Space Force (HQ USSF) Chief Strategy and Resource Office (CSRO) in the S5P Directorate. This office is responsible for managing USSFs Global Defense Posture proces ...
International Affairs Specialist

1 day ago

Deltasands Washington, United States

Delta Solutions & Strategies is seeking a International Affairs Specialist to support The Headquarters United States Space Force (HQ USSF) Chief Strategy and Resource Office (CSRO) in the S5P Directorate. This office is responsible for managing USSF's Global Defense Posture proce ...
Legislative Affairs Specialist

1 day ago

Architect of the Capitol Washington, United States

Summary · This position is located in the Architect of the Capitol (AOC), Office of Legislative and Public Affairs (LPA). The selectee will perform House legislative liaison activities between the AOC, the Congress and external stakeholders on a broad range of AOC program activi ...
Public Affairs Specialist

2 weeks ago

Vox Optima LLC Washington, United States

Responsibilities: · We need motivated candidates with communications project management, writing and editorial, and media relations experience to support a government communications contract. This position will support command communications activities, including: · Providing sup ...
Government Affairs Specialist

1 day ago

LKQ Washington, United States

Support Government Affairs Department representing the company's best interest through grassroots initiatives, interacting with state and federal industry associations, and supporting all government relations functions.Essential Job Duties:* Execute grassroots initiatives by deve ...
Intergovernmental Affairs Specialist

1 day ago

Booz Allen Hamilton Washington, United States

To achieve an organizations mission, leaders need strong team members who can create processes, communicate requirements, and develop innovative solutions throughout the execution of the mission. Whether analyzing proposed legislation, helping to bu Government, Specialist, Resear ...
Regulatory & Applications Affairs Specialist- LEGAL

2 weeks ago

FRBOG Washington, United States

Minimum Education. Bachelor's degree or equivalent experience. Minimum Experience 6 Summary. The Regulatory and Applications Affairs Specialist is a subject matter expert who handles the publication of regulations and related materials published by t Application, Specialist, Regu ...
Regulatory Affairs Specialist Project Lead

1 day ago

Cynet Systems Washington, United States

Job Description: · Responsibilities: Monitor emerging regulatory policy issues, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact R&D pipeline, regulatory ...
Regulatory Affairs Specialist Project Lead

1 week ago

Cynet Systems Washington, United States

Job Description: · Responsibilities: Monitor emerging regulatory policy issues, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact R&D pipeline, regulatory ...
Regulatory Affairs Specialist Project Lead

1 week ago

Lee Hecht Harrison Nederland B.V. Washington, United States

Fully Remote Part-Time Mon - Fri 9 AM - 1 PM EST (slight flex offered for different time zones) Candidates must be located in the US w/possibility of extension · Compensation: $ $91.00/hr · Must-Have Skills: · • 3-6 years of related experience in a pharma regulatory-related role ...
Regulatory Affairs Specialist Project Lead

1 week ago

Lee Hecht Harrison Nederland B.V. Washington, United States

Fully Remote Part-Time Mon - Fri 9 AM - 1 PM EST (slight flex offered for different time zones) Candidates must be located in the US w/possibility of extensionCompensation: $ $91.00/hrMust-Have Skills: 3-6 years of related experience in a pharma regulatory-related role open all t ...
Regulatory Affairs Specialist Project Lead I

1 week ago

Pyramid Consulting Washington, United States

Immediate need for a talented Regulatory Affairs Specialist Project Lead I (Scientific). This is a 06+ months Contract opportunity with long-term potential and is located in United States(Remote). Please review the job description below and contact me ASAP if you are interested. ...
Regulatory Affairs Specialist Project Lead I

1 day ago

Integrated Resources Washington, United States

Job Title: Regulatory Affairs Specialist Project Lead I · Location: Washington D.C., DC (Fully Remote) · Duration: 06 months + · Part-Time Role- (Mon - Fri 9 AM - 1 PM EST) · Job Description: · Fully Remote Part-Time Mon - Fri 9 AM - 1 PM EST (slight flex offered for differen ...
Regulatory Affairs Specialist Project Lead I

1 day ago

Aequor Technologies Washington, United States Part time

Fully Remote · Part-Time Mon - Fri 9 AM - 1 PM EST · SCOPE OF RESPONSIBILITIES: · " accountable for supporting regulatory policy efforts within the Regulatory Science and Policy team · " will be at ease working in a matrix environment and be able to navigate ambiguity to drive de ...
Conduct and Conflict Management Specialist

23 hours ago

George Washington University Washington, United States

The Division for Student Affairs (DSA) cultivates an inclusive community that supports connection, growth, and well-being for every student throughout their GW journey. Students are offered opportunities, services, and activities that promote connect Management, Specialist, Educa ...