Regulatory Affairs Specialist

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%

Post-Market Surveillance

• 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.