Primary Talent Partners has a new contract opening for a
Remote Regulatory Affairs Specialist with our healthcare client in Skaneateles, NY. This is a 9-month contract with a potential for extension.
Pay:$39.00 - $44.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.
Schedule: Schedule (flexible) | Remote positionDescription:
Responsible for the global coordination and the preparation of documents/packages for regulatory submissions. In this position you will also review and evaluate technical and scientific data and reports required for submission in support of global products.
Top three to five technical skill requirements- Familiar with USA and OUS device regulations (specifically EU device regulations)
- Experience with RA strategy development
- Experience with working with Cross functional team members
- Experience with interaction with external Regulators (FDA, TUV)
- Experience with working with medical devices
Essential Duties and Responsibilities:- Supports regulatory project plan execution
- Maintain awareness of regulatory requirements and ensure continued learning
- Maintain regulatory files in a format consistent with requirements
- Participate as an active team member of project teams as required
- Compile and prepare responses to questions from regulatory authorities according to plan
- Edit and proofread regulatory documentation
- Assist in preparation and review of labeling, SOP's, and other departmental documents
- Compile under supervision regulatory documents for submission
- Track status and progress of regulatory documentation
- Understand Regulatory Affairs' position in small project teams
Qualifications:- 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
Education and/or Experience:- 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 (not mandatory) preferably within a healthcare environment
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
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