Regulatory Affairs Specialist

We are seeking a Regulatory Affairs Specialist to join our team in a dynamic manufacturing facility. Sensonics International is a premier manufacturer of smell and taste testing Class I and Class II (510k exempt) medical devices.

Responsibilities include but not limited to:

• Maintain and manage the Quality Management System using the CORE Compliance Platform. Ensure that all documents are in compliance with ISO 13485:2016 standards.
• Maintain SAM and FDA registration and listings. Submit VETS report.
• Oversee GSA contract, including 5-year renewal and quarterly payments
• Maintain and manage EU and UK certifications through contract with MedEnvoy Global which serves as Sensonics International’s Authorized Reprpesentative and Regulatory Importer
• Maintain and renew the Canada Medical Devices Establishment License (MDEL). This requires also renewing Canadian small business status.

Requirements:

· writing skills necessary to create and edit regulatory documents

· the ability to work independently on compliance documents

· the ability to collaborate and communicate effectively with the customer service department, production managers, and the product development team

· Knowledge of the regulatory requirements to place medical devices in various Asian markets

· Minimum of 2 years’ experience in regulatory affairs

· Background Check, Reference Verification, Drug Testing

Education:

· Bachelors Degree or Higher

· Certificate in Regulatory Affairs (a plus, but not required)

Job Type: Full-time

Pay: $35.00 - $40.00 per hour

Expected hours: 37.5 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to Commute:

• Haddon Heights, NJ 08035 (Required)

Ability to Relocate:

• Haddon Heights, NJ 08035: Relocate before starting work (Required)

Work Location: In person

Salary : $35 - $40