R019
Located in Clearwater, FL
Pay: 150K
Job Full Description
DIRECT HIRE OPPORTUNITY – DIRECTOR OF QUALITY & REGULATORY AFFAIRS
Location: Clearwater, FL | Onsite | Relocation Assistance Available
Industry: Medical Device Manufacturing
Salary: $150K+ (Negotiable)
Benefits: Comprehensive benefits package
Join a trusted, established medical device manufacturer with over 50 years of excellence in the Tampa Bay area. We are seeking a highly experienced Director of Quality & Regulatory Affairs to lead and manage our QA/RA team. This is a direct hire position offering relocation support for the right candidate.
Position Overview
The Director of Quality & Regulatory Affairs is responsible for overseeing all aspects of the company’s quality system to ensure compliance with applicable standards and regulations. This leadership role requires strong knowledge of medical device regulations and the ability to manage both strategy and execution across QA/RA functions.
Key Responsibilities
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Lead the development, implementation, and maintenance of the company’s Quality Management System (QMS).
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Ensure compliance with all applicable regulatory requirements and standards (FDA, ISO, etc.).
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Develop and maintain quality policies, procedures, and documentation.
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Manage and mentor QA/RA staff, ensuring alignment with company goals and regulatory expectations.
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Oversee and support regulatory submissions, including 510(k)s.
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Conduct performance evaluations and support employee growth within the QA/RA department.
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Handle complaints, investigations, and CAPAs as required.
Qualifications
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Bachelor’s degree from an accredited institution required.
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Minimum 10 years of experience in Quality and Regulatory Affairs within the medical device industry.
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Experience managing a QA/RA team.
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Strong knowledge of FDA regulations and ISO standards.
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Experience with regulatory submissions (510(k), CE Mark, etc.) is a plus.
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Advanced degree preferred but not required.
How to Apply
Please send your resume to jobs.clearwaterfl@expresspros.com
Or call us at 727-712-0607 to learn more.
This is a high-impact leadership role at a company known for innovation, stability, and dedication to quality. If you're ready to take the next step in your career, we want to hear from you!
Clearwater, FL
1380
1500 North McMullen Booth Road
Suite A3
Clearwater, FL 33759
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