Global Regulatory Compliance Specialist
3 weken geleden
Job Summary
This position is responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level, with a focus on the Middle East region. The successful candidate will ensure regulatory compliance for assigned countries as the company evolves.
Main Responsibilities
- Determines global regulatory pathways for various projects, including product classification and type of regulatory submission or rationale required.
- Participates on various teams to define regulatory requirements, approval timelines, etc. for international submissions.
- Identifies guidance documents, international standards, and assists teams with their interpretation.
- Prepares regulatory submissions to regulatory authorities and/or distributors.
- Interacts with various levels of management, external agencies, and companies.
- Develops, maintains, and analyzes department systems, providing training when needed.
- Remains current on developing regulations and revises systems as necessary.
- Assists with facility inspections, Notified Body Audits, and other governmental inspections as directed.
- Contributes to continuous improvement initiatives.
- Assists with supervision of department staff, as directed.
Requirements
- Education and experience equivalent to a Bachelor's Degree in a biological, physical, engineering, or material science discipline, and six years of related experience.
- Demonstrated knowledge of global regulatory requirements, with particular emphasis on GCC medical device regulations, notably SFDA.
- Good understanding of FDA regulations, EU regulations, and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc.
- Supervisory skills are preferred.
- Demonstrated computer skills, preferably in spreadsheets, word processing, database, internet research, and other applicable software programs.
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