Senior Regulatory Affairs Specialist

BALT Group•Irvine, CA

23h•$125,000 - $130,000

About The Position

The Senior Regulatory Affairs Specialist is responsible for the coordination and preparation of regulatory submissions for new and modified medical devices, license renewals, and annual registrations. Serves as a seasoned Regulatory representative on specific multi-discipline teams and acts independently to identify and resolve problems. Applies regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of projects. Interacts directly with FDA/Notified Body/Health Canada and indirectly with international regulatory agencies on most projects/products at reviewer-level.

Requirements

Experience in Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), Pre-Market 510k, and Pre-Market Approval (PMA) applications.
Demonstrate practical knowledge of project management, in addition to 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.

Responsibilities

Develop and implement complex, global regulatory strategies.
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.
Makes improvements to department processes and systems, as called upon.
Assists with audits and inspections, as needed.
Performs other duties and responsibilities as assigned.