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Randstad Regulatory Affairs Administrator in Morrisville, North Carolina

Regulatory Affairs Administrator

job details:

  • location:Morrisville, NC

  • salary:$22 - $26 per hour

  • date posted:Monday, May 6, 2019

  • experience:3 Years

  • job type:Contract

  • industry:Professional, Scientific, and Technical Services

  • reference:28614

job description

Regulatory Affairs Administrator

job summary:

The Regulatory Affairs Administrator is responsible for determining and supporting the regulatory activities which to maintain regulatory compliance and approval for Teleflex Medical products globally.

location: Morrisville, North Carolina

job type: Contract

salary: $22 - 26 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

Key responsibilities will include (but are not limited to) the following:

· Maintenance of international product licenses

· Act as regulatory coordinator for the international region

· Logging of international market requests

· Respond to regulatory queries in a timely manner

· Update and provide metrics on international licenses as required

· Maintain international product license database

· Legalization of documents for international markets

· Review and assess of change control activities for potential impact on current regulatory filings.

· Maintenance of Regulatory procedures to ensure continued compliance.

· Support Regulatory inspections at the site as directed.

· Liaise with other departments to ensure correct supporting data generated and provided in a timely

· manner.

· Ensure all operations are fully compliant with license details and updated in accordance with relevant

guidelines and directives

qualifications:

· 2-3 years' experience in QA/RA, preferred (but we would like them to have some experience in regulated environment )

· Attention to detail and accuracy - essential

· Excellent Organizational and Communications skills

· Fluent English, both written and oral - essential

· Ability to work well under deadlines and pressure

· Problem solving skills for developing creative solutions and meeting objectives are required.

· Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel);

· The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.

skills: Regulatory Briefing Documents

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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