Job Description

Regulatory Affairs Associate

All IT Solutions

United States

Workplace Type — Remote

Employment Type — Contract

We are currently seeking a qualified Regulatory Affairs Associate to support this engagement. Please review the complete requirements, work location, employment type, and screening questions before applying. Candidates whose experience closely matches the position will be contacted directly by the AIS recruiting team.

Job Summary

All IT Solutions is seeking a Regulatory Affairs Associate to join a client engagement.

Required Qualifications

• Familiar with USA and OUS device regulations (specifically EU device regulations) -Experience with RA strategy development -Experience working with cross-functional team members -Experience with interaction with external Regulators (FDA, TUV) -Experience with working with medical devices -Knowledge of regulations -Scientific knowledge -Administrative and project management skills -Ability to contribute to multiple projects from a regulatory affairs perspective -Ability to multitask and prioritize -Interpersonal and communication skills -Technical system skills (e.g, word processing, spreadsheets, databases, online research) -Proofreading and editing skills Job Description -Responsible for the global coordination and preparation of documents/packages for regulatory submissions -Review and evaluate technical and scientific data and reports required for submission in support of global Baxter's products -Remote position with a flexible schedule -Supports regulatory project plan execution -Maintains awareness of regulatory requirements and ensures continued learning -Maintains regulatory files in a format consistent with requirements -Participates as an active team member of project teams as required -Compiles and prepares responses to questions from regulatory authorities according to plan -Edits and proofreads regulatory documentation -Assists in preparation and review of labeling, SOPs, and other departmental documents -Compiles under supervision regulatory documents for submission -Tracks status and progress of regulatory documentation -Understands Regulatory Affairs' position in small project teams

Preferred Qualifications

• Bachelor's degree or country equivalent in a relevant scientific discipline -Suitable candidates with a non-scientific degree may be accepted and undertake further training (e.g, under an apprenticeship or similar post-graduate qualification) -Regulatory experience preferred, preferably within a healthcare environment

ABOUT ALL IT SOLUTIONS LLC

Headquartered in Mount Laurel, New Jersey, All IT Solutions LLC is a technology and workforce solutions company serving government and commercial organizations throughout the United States. AIS provides IT staffing and staff augmentation, cybersecurity, IT consulting, custom software development, cloud services, data engineering, artificial intelligence, application development, and related technology solutions.

AIS is an NMSDC/EMSDC-certified Minority Business Enterprise and an NYC Department of Small Business Services-certified M/WBE. We participate in E-Verify and are committed to maintaining professional, transparent, and compliant hiring practices.

EQUAL EMPLOYMENT OPPORTUNITY

All IT Solutions LLC is an equal opportunity employer. Employment decisions are made based on qualifications, merit, performance, and legitimate business requirements without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, military or veteran status, or any other characteristic protected by applicable federal, state, or local law.

Reasonable accommodations are available to qualified applicants with disabilities during the application and interview process.

RECRUITMENT NOTICE

All IT Solutions LLC is a staffing and technology services company and may receive fees or compensation from client organizations for recruiting, staffing, placement, or workforce services. Candidates are never charged an application, recruitment, placement, or interview fee by All IT Solutions LLC.

Any commercial rates, fees, or staffing arrangements are between All IT Solutions LLC and its clients and do not require payment from the candidate.

Official recruiting communications will come from an authorized All IT Solutions representative or an @allitsolutions.us email address.

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