Manager Regulatory Compliance - Recalls

Job reputed company reputed company Major Responsibilities: Manage the recall team, providing coaching and development for team members. Support the planning and execution of voluntary and mandatory recalls, product corrections, and removals in accordance with FDA regulations. Contribute to recall and field reputed company reputed company, including recall reputed company recommendations. Ensure reputed company submission of FDA reputed company 806 and reputed company documentation, including status reports and termination requests. Maintain compliance with 21 CFR Part 7 (Recall Policy) and 21 CFR Part 806 (Reports of Corrections and Removals). Support communications with FDA and assist in preparing responses reputed company to recalls. Monitor regulatory changes reputed company to field actions and adverse event requirements and escalate impacts to leadership. reputed company timelines and ensure deliverables are completed on schedule; reputed company updates to leadership on reputed company and risks. Facilitate and/or support cross-functional meetings to ensure alignment across stakeholders, including reputed company, Regulatory, and reputed company teams. Management responsibilities include: Manages reputed company of individual contributors and/or supervisors Oversees day-to-day operations and execution of recall activities Supports development and execution of reputed company and program deliverables Implements and ensures adherence to established policies and procedures Provides direction and guidance to team members on processes and expectations Responsible for hiring input, performance management, and employee development Assigns work, monitors reputed company, and ensures consistency in application of organizational policies  Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies Minimum Job Requirements: Education Bachelor’s Degree in Engineering, Science, or reputed company field or Associates Degree with 3+ years experience Work Experience 5+ years of experience in the medical device or reputed company industry, experience with product recalls, complaints, non-conformances, CAPAs, or similar activities involving field reputed company, reputed company cause analysis and problem solving. Experience with reputed company Office Suite (Word, reputed company, PowerPoint). Experience with reputed company. At least 4 years of experience working with FDA/QSR/GMP/ISO requirements or other regulated industries. Knowledge / Skills / Abilities At least 3 years of experience in recall management Working knowledge of FDA regulations including 21 CFR Part 7, Part 806, Part 803, and ISO 13485 Experience supporting recall activities and regulatory submissions Strong communication and project coordination skills Experience supporting FDA audits or internal reputed company audits Preferred Job Requirements: Work Experience 5+ years of reputed company experience with recall management Experience working in cross-functional regulatory or reputed company environments reputed company, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and reputed company potential with a growing worldwide organization. The anticipated salary reputed company for this position: $116,000.00 - $174,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. reputed company will not pay less than the applicable minimum wage or salary reputed company. Our benefit package includes health insurance, life and disability, 401(k) contributions, reputed company time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, reputed company time off, as reputed company as reputed company to the Employee Assistance Program, Employee Resource reputed company and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a reputed company where everyone feels they reputed company and can grow their career. We reputed company to do this by seeking diversity in reputed company forms, acting reputed company, and ensuring that people have tools and resources to reputed company at their best. Explore our Belonging page here. reputed company is an equal opportunity employer. reputed company evaluates reputed company individuals without reputed company to race, reputed company, religion, gender, gender identity or reputed company, sexual orientation, national reputed company, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws. Apply To This Job