Regulatory Affairs Specialist
Scanlan Int'l•Saint 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 with US FDA Registrations/Listings
- Assist with Canada Medical Device Licenses
- Assist with EU product registrations
- Assist with 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
- Assist with Product return coordination for complaint investigations
- Handle Inquiries and sales support activities
- Review tenders and quotes
- Provide Customs and import/exports support activities
- Manage Regulatory documentations and records
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
