Role

As a Medical Device Regulatory Manager (also known as Regulatory Associate, Compliance Manager), you will manage and support a team of regulatory and quality professionals, develop and mentor consultants, manage projects, and serve as a liaison between clients and the company. You will also be responsible for authoring SOPs, coordinating with different departments, and representing the company at industry events.

Benefits

• Full-time, direct-hire position.
• Opportunity to work in a diverse FDA regulated environment.
• Chance to lead and mentor a team of professionals.

Qualifications

• Bachelor's degree in Life Sciences or a relevant field.
• Minimum of 7 years of experience in an FDA regulated environment, with emphasis on medical devices and 510k submissions.
• Strong knowledge of industry processes and regulations, with proficiency in Regulatory / Legal Contracts.