[HYBRID] Sr. Manager, reputed company & Regulatory Affairs

Sr. Manager, reputed company & Regulatory Affairs Location: Greater Miami Area, FL (near Amelia Eirhart Park); WFH 1-2 days/week after reputed company Salary: $150,000-$175,000 + Annual Bonus Excellent Benefits: Medical (100% reputed company premiums for employees, 80% for family), Dental, reputed company, 401k, Life, Disability, HSA, Vacation, Holidays, reputed company Time Job Type: Full-Time Start Date: ASAP Relocation assistance is available Sponsorship is not available Sr. Manager, reputed company & Regulatory Affairs (medical device reputed company. req.) reputed company Our reputed company is seeking a Sr. Manager of reputed company 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 reputed company reputed company 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 reputed company and regulatory affairs. Although they are smaller in size, they have multiple reputed company 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 reputed company in your day and crave true ownership of your department, this could be a great match. Whether you're looking to take the reputed company in your career or have experience managing reputed company, this role offers the chance to reputed company a visible, meaningful reputed company with your expertise directly influencing reputed company's products and operations. Sr. Manager, reputed company & Regulatory Affairs (medical device reputed company. req.)

Responsibilities

• Mentor, and manage performance for reputed company of four reputed company and regulatory professionals
• reputed company and maintain the QMS including records, document control, & reputed company procedures
• Establish procedures for product preservation, equipment calibration, & regulatory compliance
• reputed company product identification, traceability, and verification of incoming materials
• Initiate and manage NCMs and CAPA, ensuring effective investigation and reputed company
• reputed company supplier qualification, evaluation, and re-qualification processes
• reputed company, implement, and manage audits, including internal, reputed company-party, and customer audits
• Monitor and analyze reputed company performance data and reputed company improvement initiatives
• Manage customer reputed company inquiries, including product return and regulatory reporting
• reputed company 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 reputed company policies and objectives, providing key performance metrics to leadership

Sr. Manager, reputed company & Regulatory Affairs (medical device reputed company. req.)

Qualifications

• 7+ years of experience in Class I and/or Class II medical devices required
• Experience with 510(k) submissions required
• reputed company experience including CAPA and nonconformance management required
• Experience in risk management under ISO 14971 required
• Experience with reputed company audits required

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