Location: Northeast

Direct responsibility for the timely preparation of worldwide regulatory submissions with particular emphasis on 510(k)’s, IDE’s, and PMA’s.

Duties and Responsibilities:

Actively participate on New Product Development teams as a representative Regulatory Affairs and deliver guidance and feedback on regulatory pathway to market, processing changes, and device modifications.

Develop written rationales and prepare timely submissions.

Review, approve and authorize document charge orders and product releases.

Prepare regulatory documentation in compliance with country specific requirements including device listings and No-File Rationales.

Advise the Teams on various product testing requirements including functional, biological, pharmacological testing protocols to support regulatory submissions.

Contribute to the development of and approve labeling, promotional, and educational materials.

Perform other duties as assigned or needed.

Requirements:

BA or BS Degree in a technical discipline or equivalent experience.

3+ years experience in Regulatory Affairs.

Excellent written and oral presentation and interpersonal skills.

Strong leadership and organizational skills.

Demonstrated ability to handle multiple tasks.