Regulatory Affairs Associate I

About the role

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 client’s products. Location: Skaneateles, NY (Remote). Duration: 12 Months.

Schedule

Flexible

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

Skills

• 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

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 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 preferably within a healthcare environment