[HYBRID] Sr. Manager, Quality & Regulatory Affairs
Sr. Manager, Quality & Regulatory Affairs Location: Greater Miami Area, FL (near Amelia Eirhart Park); WFH 1-2 days/week after onboarding 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 Start Date: ASAP Relocation assistance is available Sponsorship is not available Sr. Manager, Quality & Regulatory Affairs (medical device exp. req.) Description Our client is seeking a Sr. Manager 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. Sr. Manager, 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
Sr. Manager, Quality & Regulatory Affairs (medical device exp. req.)
Qualifications
- 7+ years of experience in Class I and/or Class II medical devices required
- Experience with 510(k) submissions required
- Quality experience including CAPA and nonconformance management required
- Experience in risk management under ISO 14971 required
- Experience with internal and external audits required
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