Regulatory Affairs Specialist

Scanlan Int'l•St. Paul, MN

About The Position

The Regulatory Affairs Specialist will assist in maintaining market authorizations for Scanlan products, including design files, technical documentation, product registrations and listings. They will also assist with post-market surveillance and post-delivery regulatory activities necessary to ensure Scanlan products remain state-of-the-art for worldwide markets.

Requirements

Bachelor’s degree in life sciences or other related field.
1 - 3 years of regulatory affairs work experience with medical devices.
Computer proficiency in Microsoft Office applications.
Excellent communication skills, especially written communications.
Excellent organizational and record keeping skills.
Attention to detail with excellent proofreading, writing and editing skills.
Good team player with a collaborative work style.

Nice To Haves

Master of Science – Regulatory Affairs
Preparing and submitting regulatory submissions.

Responsibilities

Assist in maintaining market authorizations for Scanlan products, including design files, technical documentation, product registrations and listings.
Assist with post-market surveillance and post-delivery regulatory activities necessary to ensure Scanlan products remain state-of-the-art for worldwide markets.
US FDA Registrations/Listings
Canada Medical Device Licenses
EU product registrations
Rest of World product registrations
Maintain product submissions
Maintain CE certification
Maintain CFGs
Maintain D of Cs
Maintain Product Lists
Update design files, technical files, risk files, and other technical documentation based post-market surveillance data and trends.
Assist with CAPA and Complaint investigations and record keeping
Product return coordination for complaint investigations
Inquiries and sales support activities
Tender and quote reviews
Customs and import/exports support activities
Regulatory documentations and records management