Regulatory Affairs Specialist

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 specializing in the highest-quality surgical instruments. Now in our fourth generation, the Scanlan family continues its dedication to providing the best surgical instrumentation available anywhere in the world. We are seeking a Regulatory Affairs Specialist to join our organization and continue this commitment.

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.

This position is based out of our headquarters office, south of downtown St. Paul. We welcome an on-site work environment Monday through Friday.

What You'll Do As a Regulatory Affairs Specialist:

30% of your time will be spent assisting with the following Market Authorization

• 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% of your time will be spent working with Post-Market Surveillance

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

30% of your time assisting with Post Delivery Activities

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

10% of your time will be spent on General Regulatory Affairs Support

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

The Experience, Skills and Abilities Needed:

Required

Education:

• Bachelor's degree in life sciences or other related field. Master of Science - Regulatory Affairs preferred

Experience:

• 1 - 3 years of regulatory affairs work experience with medical devices.
• Experience in preparing and submitting regulatory submissions is preferred

Skills:

• Computer proficiency in Microsoft Office applications.
• Excellent communication skills, especially in 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.

Compensation

We are committed to equitable and transparent pay practices. The salary range for this position is $50,000 - $80,000, representing the minimum and maximum of our compensation structure. Starting pay will typically fall between these values and is determined based on factors such as relevant experience, skills, and internal equity. Offers near the higher end of the range are reserved for candidates with exceptional qualifications.

• 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, including:

• Holidays
• Floating Holidays
• Vacation
• Earned Sick and Safe Time (ESST)

Scanlan International is an EEO employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as protected veteran.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please click the following link to view Federal and E-Verify posters: https://www.e-verify.gov/employees