Global Regulatory Affairs Specialist – Medical Devices

Scanlan International, Inc.; Minneapolis, Saint Paul (MN, MN); On-site; USD 50,000 - 80,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

Group Life Insurance

Short-Term Disability Insurance

Long-Term Disability Insurance

401(k) Plan with Company Match

Workers' Compensation

Employee Assistance Program (EAP)

Training and Development Program

Tuition Assistance Program

Paid Time Off

Job summary

Scanlan International, Inc. is a medical device company seeking a Regulatory Affairs Specialist to maintain market authorizations and oversee regulatory documentation for worldwide markets. The role is based at the headquarters south of downtown St.

Paul with an on-site work environment Monday through Friday. Responsibilities include FDA/Canada/EU registrations, post-market surveillance, CAPA investigations, and regulatory records management.

Qualifications

• Bachelor's degree in life sciences or related field; MS in Regulatory Affairs preferred.
• 1–3 years regulatory affairs experience with medical devices.
• Experience in preparing and submitting regulatory submissions preferred.

Responsibilities

• Assist with US FDA registrations/listings, Canada licenses, EU and RoW registrations.
• Maintain product submissions, CE certification, CFGs, D of Cs and product lists.
• Support post-market surveillance with updated technical/design files and trends.
• Assist with post-delivery activities including CAPA and complaint investigations.

Skills

Microsoft Office

Communication

Organization

Proofreading

Team player

Education

Bachelor's degree in life sciences

MS - Regulatory Affairs preferred

Job description

Scanlan International, Inc. is a medical device company seeking a Regulatory Affairs Specialist to maintain market authorizations and oversee regulatory documentation for worldwide markets. The role is based at the headquarters south of downtown St.

Paul with an on-site work environment Monday through Friday. Responsibilities include FDA/Canada/EU registrations, post-market surveillance, CAPA investigations, and regulatory records management.