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.
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
Qualifikationen
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 preferably within a healthcare environment
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
Notes:
Schedule (flexible)
Remote position
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status
