Quality and Regulatory Manager
Reports to: Vice President, Marketing and Commercialization
Job Responsibilities:
- Short term collaboration with 3rd party partner to manage and maintain current QMS.
- Migrate QMS from 3rd party partner to implement and manage internal QMS system.
- Perform necessary quality related requirements on incoming inventory shipments.
- Receive and product complaints, implement and manage any needed CAPA.
- Update necessary product FDA registration, when required.
- Prepare, submit and manage country approval submissions.
- Assist in company compliance program by periodically notifying distribution. partners of Voom compliance policy, requirements and updates.
Desired Qualifications and Experience:
- Experience in Med Device or similar highly regulated industry required.
- Experience managing or maintaining a company QMS.
- Experience in preparing a submitting country approvals.
- Desire to work for a small, growing organization in a fast-paced environment.
- A Commercially minded individual who looks for ways to maintain a compliant. QMS, while removing unnecessary administrative barriers to commercialization.
