Regulatory Affairs Specialist II

Cook Group•Vandergrift, PA

About The Position

The Regulatory Affairs Specialist II plans and prepares submissions to obtain regulatory approvals for new and modified medical devices in specific markets. The role develops regulatory strategies, obtains and maintains approvals, and serves as a communication liaison between the Cook manufacturer and Cook International Local Office or Cook Distributor.

Requirements

Proficient in reading, writing, and speaking English.
Bachelor’s degree in a relevant technical or scientific discipline.
Knowledge of medical device quality standards and regulatory requirements.
Three years of experience in the medical device industry.
Computer experience, including working knowledge of Microsoft.

Responsibilities

Maintain an understanding of global medical device regulations, including ISO 13485, MDR 2017/745, and FDA 21 CFR Part 820, as well as other applicable regulations.
Serve as a liaison on regulatory issues between the Cook manufacturer, Cook Local Office and/or Cook Distributor, and Notified Body.
Prepare regulatory submissions for new products, product changes, and re-registrations for specific regions.
Create, organize, and maintain technical documentation.
Maintain registration information, including license numbers and expiration dates, and obtain re-registration approvals before licenses expire to avoid product availability disruptions.
Support currently marketed products, including providing input on or creating change requests.
Support post-market regulatory activities, including Post Market Surveillance Plans, Post Market Clinical Follow Up (PMCF) Plans and Reports, and Periodic Safety Update Reports (PSURs).
Maintain and organize regulatory records to demonstrate compliance with applicable regulations.
Multi-task and work within defined deadlines.
Interpret regulations and apply them to practical scenarios.
Interact effectively and professionally with colleagues across levels of the global organization.
Maintain regular and punctual attendance and meet company quality and quantity standards.
Communicate effectively orally and in writing.
Solve problems and work collaboratively or independently with minimal supervision.
Remain calm and receptive in fast-paced situations.