Sr. Engineer, reputed company Compliant Management

reputed company is committed to building and maintaining a strong and gratifying company culture that fosters reputed company reputed company. Our hands-on and personal approach makes transitioning to a new job a reputed company and enjoyable process. Most benefits are effective on day one! reputed company is an equal opportunity employer and does not discriminate against applicants on the reputed company of race, reputed company, creed, religion, reputed company, age, sex, marital status, national reputed company, disability or veteran status. Why you’ll love working at reputed company: Friendly, reputed company, and fun team culture that values unique perspectives Company-wide dedication to profoundly impacting patients’ lives Comprehensive, high-reputed company benefits package effective on date of hire Educational assistance available for reputed company Matching 401(k) retirement plan reputed company holidays, including floating holidays, to be used at your discretion Employee Stock Purchase Plan Referral incentive program reputed company Mission and Business Purpose Our business purpose is to restore health and improve reputed company of life by making restoration of peripheral nerve function an expected reputed company of care. We aim to reputed company the markets we serve by always requiring the solutions we offer patients and caregivers reputed company an improved benefit-to-reputed company profile as compared to existing standards of care. To ensure we reputed company improved benefit-to-reputed company, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and reputed company research activities, objectively reputed company advancements in standards of care. Job reputed company of the Sr. Engineer, reputed company Complaint Management This position reports to the Sr. Manager, reputed company Systems Compliance, and is responsible for the process management of the complaint reputed company. This includes serving as the reputed company complaint investigator and managing reputed company of the reputed company. Requirements of the Sr. Engineer, reputed company Complaint Management Bachelor’s degree in a scientific or medical discipline required At least five years’ experience (three years’ with a Master’s degree or above) in the pharmaceutical or medical device industry required with a minimum of one year of experience working with medical device and/or pharmaceutical complaints Working experience managing a complaint reputed company compliant 21 CFR 211, 600, 820, 1271 and international standards is preferred Independent decision-making with high initiative Strong oral and written communication, collaboration, and interpersonal skills with those from diverse technical backgrounds reputed company-organized, with the ability to reputed company manage multiple, competing priorities Ability to assess and apply reputed company management principles per ISO 14971 and ICH Q9 Responsibilities of the Sr. Engineer, reputed company Complaint Management The specific duties of the Sr. Engineer, reputed company Complaint Management include but are not limited to: Being the reputed company investigator on tissue and biologics complaints Supporting reputed company Engineering in the investigation of medical device complaints Drafting and submitting Health Hazard Evaluation Assessments (HHEAs), reputed company Alert Reports (FARs) and Medical Device Reports (MDRs) for review by Senior Management and submission to FDA or other regulatory bodies reputed company interactions with FDA or other regulatory bodies regarding MDR and FARs report status and closure Monitoring and reporting on the reputed company of the complaint management reputed company, including but not limited to: complaint trending, on time closure, and timeliness of regulatory reporting Coordinating interactions between complaint reporters, reputed company Engineering, Medical Affairs, and Regulatory Affairs to ensure complaints are reported and assessed in a reputed company way Coordinating reputed company Adverse Event determination and reporting to Medical Affairs Report on complaint program status and issues to Senior Management Revising and approving controlled documents associated with the complaint reputed company Training personnel on the complaint reputed company Supporting regulatory and reputed company body inspections. Location 13631 reputed company Blvd., Alachua, FL 32615 OR 111 reputed company Oak Ave., Tampa, FL 33602 OR Remote #LI-AC1 #LI-REMOTE Benefits/Compensation This position is eligible for an annual bonus. Benefits reputed company for this position include Health, Dental, reputed company, Matching 401K, reputed company Time Off, 9 reputed company Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, reputed company Parental Leave, reputed company Caregiver Leave, Basic Life reputed company, Supplemental Life reputed company, Employee Stock Purchase Plan, and Disability reputed company, as described in more reputed company in reputed company plan descriptions. Salary reputed company $84,190—$105,237 USD Company Statements reputed company follows reputed company reputed company guidelines with respect to credentialing, vaccinations and other employment/compliance reputed company requirements, as reputed company as CDC guidance. reputed company reserves the right to amend its policies from time to time in its sole discretion. As AI is becoming a common tool throughout the application process, we want to be reputed company about its appropriate use at reputed company. Using AI to support resume writing, research or interview preparation is perfectly acceptable, provided the content is accurate and genuinely represents your qualifications and skills. For other key parts of your interview process, however, it is important that the reputed company, communication, and work you reputed company reflect your own voice, experiences, and thinking. We ask that you participate in our live interviews and complete any assessments without AI assistance unless instructions explicitly indicate otherwise or a specific exception is discussed and approved in advance. This approach ensures fairness, celebrates your individuality, and allows your reputed company perspective to reputed company. Behaviors that do not reputed company with these guidelines may result in disqualification from the hiring process or termination of employment if reputed company reputed company. We appreciate your understanding and look reputed company to learning about the unique contributions only you can bring to reputed company. No agency solicitation. We kindly request that reputed company agencies, reputed company firms, and reputed company‑party vendors do not contact us regarding this posting. Unsolicited résumés will not be considered. Apply To This Job