Senior Principal Regulatory Affairs Specialist

BALT Group•Irvine, CA

1d•Onsite

About The Position

The Sr. Principal Regulatory Affairs Specialist is a seasoned expert, responsible for completing and maintaining regulatory approvals/clearances for new and modified medical devices, license renewals, and annual registrations. Serves as a Regulatory representative on specific multi-discipline teams, responsible for organizing and leading meetings and acts independently to identify and resolve problems that may be complex in nature. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of projects. Interacts directly with regulatory bodies.

Requirements

Experience in Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), and Pre-Market Approval (PMA) applications
Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.
Ability to work well in a team environment.
Works well under pressure in a dynamic, timeline-driven environment
Demonstrated MS Office and Adobe Acrobat software skills
Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.
Nine (9) + years of professional regulatory experience.
Documented experience in preparation of US and EU submissions
Experience interfacing with relevant regulatory authorities through all stages of device life cycle.
Must be able to remain in a stationary position 50%
Constantly operate a computer and other office equipment, such as copy machine, printer, etc.
Working conditions are normal for an office environment.

Responsibilities

Develop and implement global regulatory strategies for complex, high-risk medical devices including contingency plans.
Represent Regulatory Affairs on project teams and partners with cross-functional teams to ensure alignment of regulatory strategies and organizational objectives.
Writes, reviews and files regulatory submissions and documentation for the US and internationally.
Support product maintenance for currently marketed products, as necessary.
Reviews device labeling for compliance with the applicable US and international regulations.
Reviews product and manufacturing changes for compliance with applicable regulations.
Reviews advertising and promotion to ensure compliance with product claims
Documents, consolidates, and maintains verbal and written communication with regulatory agencies.
Identify and evaluate regulatory processes and systems for improvements ensuring compliance
Assists with audits and inspections, as needed
Performs other duties and responsibilities as assigned.