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.

Government Affairs Specialist

3 weeks 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

3 weeks 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 ...
Legislative Affairs Specialist

5 days ago

Headquarters, NASA Washington, United States

Summary This position is in the Office of Legislative and Intergovernmental Affairs (OLIA). As a Legislative Affairs Specialist, you will be responsible for coordinating with internal and external partners of OLIA, in support of the legislative agenda for the Agency. Responsibili ...
Regulatory Affairs Specialist

3 weeks 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 ...
Intergovernmental Affairs Specialist

1 week ago

Booz Allen Hamilton Washington, United States

Intergovernmental Affairs Specialist · The Opportunity: · To achieve an organization's mission, leaders need strong team members who can create processes, communicate requirements, and develop innovative solutions throughout the execution of the mission. Whether analyzing propose ...
Legislative Affairs Specialist

5 days ago

NASA Washington, United States

This position is in the Office of Legislative and Intergovernmental Affairs (OLIA). As a Legislative Affairs Specialist, you will be responsible for coordinating with internal and external partners of OLIA, in support of the legislative agenda for the Agency. Specialized experien ...
congressional affairs specialist

1 week ago

DHS Headquarters Washington, United States

Summary This position is located in the Department of Homeland Security (DHS), Office of Legislative Affairs (OLA). The primary purpose of this position is to perform the full range of congressional work including controlling, analyzing, researching, and formulation of official r ...
Congressional Affairs Specialist

1 week 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 week 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 ...
Congressional Affairs Specialist

1 week 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 ...
Legislative Affairs Specialist

1 week ago

Commerce International Trade Administration Washington, United States

Summary This vacancy is for a Legislative Affairs Specialist in the International Trade Administration (ITA), within the Department of Commerce. The position serves as the Deputy Director, in the Office of Legislative Affairs, ITA. Responsibilities As a Legislative Affairs Specia ...
External Affairs Specialist

1 week ago

Federal Housing Finance Agency Washington, United States

Summary · Please ensure you read the below overview and requirements for this employment opportunity completely. · The employee will report to the Stakeholder Relations section in the Office of Congressional Affairs and Communications (OCAC) to support a wide range of Agency com ...
Legislative Affairs Specialist

22 hours ago

Headquarters, NASA Washington, United States

Location: · Location: Washington, District of Columbia, 20080 · Company: · Location: Washington, District of Columbia, 20080 Company: Headquarters, NASA Apply for this job Summary This position is in the Office of Legislative and Intergovernmental Affairs (OLIA). As a Legislat ...
International Affairs Specialist

1 week 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 ...
Congressional Affairs Specialist

1 week 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 ...
Legislative Affairs Specialist

1 week ago

Commerce, International Trade Administration Washington, United States

Summary This vacancy is for a Legislative Affairs Specialist in the International Trade Administration (ITA), within the Department of Commerce. The position serves as the Deputy Director, in the Office of Legislative Affairs, ITA. Responsibilities As a Legislative Affairs Specia ...
Intergovernmental Affairs Specialist

6 days ago

Booz Allen Hamilton Washington, United States

Job Number: R · Intergovernmental Affairs Specialist · The Opportunity: · To achieve an organization's mission, leaders need strong team members who can create processes, communicate requirements, and develop innovative solutions throughout the execution of the mission. Whether ...
Congressional Affairs Specialist

6 days ago

U.S. Department of Transportation Washington, United States

Summary · This Office of the Assistant Secretary for Governmental Affairs liaisons with Congress for the purpose of explaining Departmental programs for DOT-sponsored legislation and promote the cooperative participation by State and local governments. Additionally, presents the ...
Congressional Affairs Specialist

5 days ago

U.S. Department of Transportation Washington, United States

Summary · This Office of the Assistant Secretary for Governmental Affairs liaisons with Congress for the purpose of explaining Departmental programs for DOT-sponsored legislation and promote the cooperative participation by State and local governments. Additionally, presents the ...
International Affairs Specialist

1 week 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 ...