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 specified markets. The role develops regulatory strategies, obtains and maintains approvals, and acts as a communication liaison between Cook manufacturers and Cook International Local Offices or distributors. The Specialist supports compliance with applicable global medical device regulations and standards, maintains regulatory documentation and registration information, and supports regulatory activities for marketed products and post-market surveillance.

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 and working knowledge of Microsoft applications.
Strong attention to detail, organizational skills, and project management skills.
Ability to interpret and apply regulations, multitask, and meet defined deadlines.
Effective oral and written communication skills.
Ability to solve problems and work collaboratively or independently with minimal supervision.

Responsibilities

Maintain an excellent understanding of global medical device regulations, including ISO 13485, MDR 2017/745, FDA 21 CFR Part 820, and other applicable requirements.
Serve as a liaison on regulatory issues between Cook manufacturers, Cook Local Offices, Cook Distributors, and Notified Bodies.
Prepare regulatory submissions for new products, product changes, and re-registrations in specified 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 disruptions in product availability.
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 Plans and Reports, and Periodic Safety Update Reports.
Maintain and organize regulatory records to demonstrate compliance with applicable regulations.
Work effectively within defined deadlines and manage multiple tasks.
Interpret regulations and apply them to real-world scenarios.
Interact professionally and effectively with colleagues at all levels of the global organization.
Maintain regular and punctual attendance and meet company quality and quantity standards.
Communicate effectively in oral and written forms.
Solve problems and work collaboratively or independently with minimal supervision.
Remain calm and receptive in fast-paced situations.