Director of Quality & Regulatory Affairs
twiceasnice Recruiting, Miami, FL, United States
Director of Quality & Regulatory Affairs
Location: Greater Miami Area, FL
(near Amelia Eirhart Park); 100% Onsite Salary: $150,000-$175,000 + Annual Bonus Excellent Benefits: Medical (100% paid premiums for employees, 80% for family), Dental, Vision, 401k, Life, Disability, HSA, Vacation, Holidays, Sick Time Job Type: Full-Time Relocation assistance is available Sponsorship is not available
Director of Quality & Regulatory Affairs (medical device exp. req.) Description
Our client is seeking a Director of Quality and Regulatory Affairs to join their Executive Leadership Team. This small but highly effective organization manufactures its own med devices while providing end-to-end design and development services. You will oversee a team of four while maintaining a hands‑on role in daily initiatives, including nonconformance investigations and CAPA. This is an ideal opportunity for someone with depth in both quality and regulatory affairs. Although they are smaller in size, they have multiple projects simultaneously, so you’ll always feel challenged. If you prefer a slower‑paced environment with more siloed responsibilities and routine, this may not be the right match. However, if you enjoy more variety in your day and crave true ownership of your department, this could be a great match. Whether you’re looking to take the next step in your career or have experience managing a team, this role offers the chance to make a visible, meaningful impact with your expertise directly influencing the company’s products and operations.
Director of Quality & Regulatory Affairs (medical device exp. req.) Responsibilities
Mentor, and manage performance for a team of four quality and regulatory professionals
Lead and maintain the QMS including records, document control, & quality procedures
Establish procedures for product preservation, equipment calibration, & regulatory compliance
Oversee product identification, traceability, and verification of incoming materials
Initiate and manage NCMs and CAPA, ensuring effective investigation and resolution
Lead supplier qualification, evaluation, and re‑qualification processes
Develop, implement, and manage audits, including internal, third‑party, and customer audits
Monitor and analyze quality performance data and continuous improvement initiatives
Manage customer quality inquiries, including product return and regulatory reporting
Direct regulatory activities for medical device products, including 510(k) submissions
Ensure organizational compliance with FDA regulations and ISO 13485 standards
Maintain SOPs, review product labeling, and monitor regulatory changes
Establish quality policies and objectives, providing key performance metrics to leadership
Director of Quality & Regulatory Affairs (medical device exp. req.) Qualifications
Bachelor’s degree required
7+ years of experience in Class I and/or Class II medical devices required
Full‑cycle development experience including design verification and validation required
QMS experience under ISO 13485, including CAPA and nonconformance management, required
Experience in risk management under ISO 14971 required
Able to work onsite each day required
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(near Amelia Eirhart Park); 100% Onsite Salary: $150,000-$175,000 + Annual Bonus Excellent Benefits: Medical (100% paid premiums for employees, 80% for family), Dental, Vision, 401k, Life, Disability, HSA, Vacation, Holidays, Sick Time Job Type: Full-Time Relocation assistance is available Sponsorship is not available
Director of Quality & Regulatory Affairs (medical device exp. req.) Description
Our client is seeking a Director of Quality and Regulatory Affairs to join their Executive Leadership Team. This small but highly effective organization manufactures its own med devices while providing end-to-end design and development services. You will oversee a team of four while maintaining a hands‑on role in daily initiatives, including nonconformance investigations and CAPA. This is an ideal opportunity for someone with depth in both quality and regulatory affairs. Although they are smaller in size, they have multiple projects simultaneously, so you’ll always feel challenged. If you prefer a slower‑paced environment with more siloed responsibilities and routine, this may not be the right match. However, if you enjoy more variety in your day and crave true ownership of your department, this could be a great match. Whether you’re looking to take the next step in your career or have experience managing a team, this role offers the chance to make a visible, meaningful impact with your expertise directly influencing the company’s products and operations.
Director of Quality & Regulatory Affairs (medical device exp. req.) Responsibilities
Mentor, and manage performance for a team of four quality and regulatory professionals
Lead and maintain the QMS including records, document control, & quality procedures
Establish procedures for product preservation, equipment calibration, & regulatory compliance
Oversee product identification, traceability, and verification of incoming materials
Initiate and manage NCMs and CAPA, ensuring effective investigation and resolution
Lead supplier qualification, evaluation, and re‑qualification processes
Develop, implement, and manage audits, including internal, third‑party, and customer audits
Monitor and analyze quality performance data and continuous improvement initiatives
Manage customer quality inquiries, including product return and regulatory reporting
Direct regulatory activities for medical device products, including 510(k) submissions
Ensure organizational compliance with FDA regulations and ISO 13485 standards
Maintain SOPs, review product labeling, and monitor regulatory changes
Establish quality policies and objectives, providing key performance metrics to leadership
Director of Quality & Regulatory Affairs (medical device exp. req.) Qualifications
Bachelor’s degree required
7+ years of experience in Class I and/or Class II medical devices required
Full‑cycle development experience including design verification and validation required
QMS experience under ISO 13485, including CAPA and nonconformance management, required
Experience in risk management under ISO 14971 required
Able to work onsite each day required
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