Quality and Regulatory Filing Specialist for Medical Devices and Drug Products

The successful candidate for the Quality and Regulatory Filing Specialistrole will:

· Track annual regulatory licensing/filings to ensure timely renewal for FDA, EUDAMED, UK MDR, etc.

· Maintain expert knowledge of applicable regulatory standards and guidance’s as they update

· FDA filings, such as annual registration, annual reports, safety reports, 510K, ANDA revisions, etc.

· Assist management team with interpretation of requirements for import of Medical Devices and Drugs into foreign countries

· Support of Class I and II medical device history and master files

· Support of quality assurance tasks such as supplier evaluations, process and equipment validations, audits, etc.

Primary Working Relationships

· Reports directly to QA Manager, interacts with internal and external contacts, and operations personnel.

Job Type: Full-time

Pay: $20.00 - $25.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Work Location: In person