Regulatory Affairs Specialist

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

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.