Regulatory Affairs (RA) position with a scope defined by RA Management. Responsibilities include contributing to regulatory submissions with direct supervision from Regulatory Management or other RA staff. They will be responsible for supporting global regulatory partners to help fulfill regulatory requirements in different countries.
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.
