Regulatory Affairs Specialist

Scanlan International; Saint Paul (MN); On-site; USD 60,000 - 85,000; Full time

Job summary

Scanlan International in Saint Paul, MN, is seeking a Regulatory Affairs Specialist to support market authorizations for medical devices across worldwide markets.

Responsibilities include maintaining US FDA registrations/listings, CE documentation, post-market surveillance, and post-delivery regulatory activities, with emphasis on accuracy and timely submissions. Bachelor’s degree and 1–3 years regulatory experience required; Master’s in Regulatory Affairs preferred.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 1–3 years of regulatory affairs work experience with medical devices.
• Excellent written communication and organizational skills.
• Attention to detail with strong proofreading and editing abilities.

Responsibilities

• Maintain market authorizations for medical devices across US, Canada, EU, and Rest of World.
• Update design, technical, risk, and other post-market documentation.
• Assist with post-delivery regulatory activities and CAPA/complaint investigations.
• Provide regulatory support for inquiries, tender reviews, and import/export activities.

Skills

MS Office

Written communication

Organization

Attention to detail

Team player

Education

Bachelor's degree in life sciences

Master of Science – Regulatory Affairs

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Regulatory Affairs Specialist

Regular Full-Time Scanlan International, Inc., St. Paul, MN, US

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.

Position Responsibilities / Essential Functions:

Percentage Time

Accountability

30%

Market Authorization(assist with the following)

• 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

30%

• Update design files, technical files, risk files, and other technical documentation based post-market surveillance data and trends.

30%

Post Delivery Activities(assist with the following)

• CAPA and Complaint investigations and record keeping
• Product return coordination for complaint investigations

10%

General Regulatory Affairs Support

• Inquiries and sales support activities
• Tender and quote reviews
• Customs and import/exports support activities
• Regulatory documentations and records management

QUALIFICATIONS:

Required Qualifications:

Education:

• Bachelor’s degree in life sciences or other related field.

Experience:

• 1 - 3 years of regulatory affairs work experience with medical devices.

Skills:

• 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.

Preferred Qualifications:

Education:

• Master of Science – Regulatory Affairs

Experience:

• Preparing and submitting regulatory submissions.