Essential Job Duties and Responsibilities:
- Organize, update, and maintain regulatory documentation in accordance with company policy and procedures.
- Assist in audit preparation when needed.
- Support review and maintenance of product labeling.
- Aid in the completion of the following tasks:
- Assist with the preparation of regulatory submissions globally.
- Initiation, collection, and coordination of information for regulatory documents for various purposes.
- Coordination with global/local RA counterparts to obtain product approvals and renewals.
- Conduct research about new regulations and guidance documents.
- Develop and review corporate and department procedures.
- Begin to be able to analyze and understand regulatory requirements and identify solutions; provide possible suggestions for implementation.
- Ensures accurate population of databases for tracking global product registrations.
Knowledge, Skills, and Abilities:
- Ability to work effectively with multiple disciplines and personalities.
- Self-starter starter, with the ability to work and learn independently.
- Demonstrate initiative and can work both independently and collaboratively in a team structure.
- Strong attention to quality/detail.
- Strong interpersonal and communication skills (written and verbal).
- Ability to handle multiple tasks and priorities.
- Proficient with computer and standard software programs (Microsoft Office, Adobe Pro).
- Excellent organizational, time management, and administrative skills.
Training and Education:
Bachelor’s degree or equivalent. Science background preferred.
Experience:
1+ years in regulatory affairs or equivalent. Medical device/IVD industry preferred.
