Regulatory Affairs Specialist II

Overview

The Regulatory Affairs Specialist II is responsible for the planning and preparation of submissions to obtain regulatory approvals for new and modified medical devices in specific markets. The Regulatory Affairs Specialist II develops regulatory strategies, obtains and maintains approvals, and serves as a communication liaison between the Cook manufacturer and the Cook International Local Office / Cook Distributor.

Responsibilities

• Maintain an excellent understanding of global medical device regulations regarding the following: ISO 13485, MDR 2017/745, FDA 21 CFR Part 820 and others as required. • Serve as a liaison on regulatory issues between the Cook manufacturer and Cook Local Office and/or Cook Distributor and Notified Body.• Prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific regions.• Create, organize, and maintain technical documentation.• Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.• Provide support to currently marketed products as necessary including input on/ creation of change requests, etc.• Support post market regulatory activities such as Post Market Surveillance Plans, Post Market Clinical Follow Up (PMCF) Plans and Reports, and Periodic Safety Update Reports (PSURs).

• Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.• Ability to multi-task and work within defined deadlines.• Ability to interpret regulations and apply them to real-world scenarios.• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.• Detail-oriented with strong organizational and project management skills.• Maintain regular and punctual attendance.• Must maintain company quality and quantity standards.• Must have effective oral and written communication skills.• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision.• Ability to remain calm and receptive in fast paced situations.

Qualifications

• Proficient in reading, writing and speaking English language.• Bachelor’s degree in relevant technical or scientific discipline.• Knowledge of medical device quality standards and regulatory requirements.• 3 years of experience in the medical device industry.• Computer experience required with working knowledge of Microsoft

 

Physical Requirements:

• General office environment • Sits for extended periods• Requires close visual acuity when working with computers, etc.• Requires occasional early morning or late evening teleconferences• International and domestic travel as required