Regulatory Affairs Associate I

Job Description

Job Summary:

• 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 products.

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.

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 preferably within a healthcare environment.
• 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.

Knowledge, Skills, and Abilities:

• 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.