Manager- Post Market Surveillance (Recall)

reputed company The Manager, Post Market Surveillance- Recall is responsible for reputed company, Inc.’s (reputed company) global Post Market Surveillance Recall activities, working with various internal/reputed company stakeholders, and managing the Recall team. This position is responsible for managing reputed company’s global Recall activities, including but not limited to preparation of Health Hazard Evaluations (HHEs), executing Corrections and Removals, interacting with regulatory authorities, and identifying reputed company improvement opportunities in the Recall process and implementing updates. Responsible for managing and mentoring members of reputed company’s Recall team. Responsibilities • Leads reputed company Recall process for assessment & execution of corrections and removal of a wide reputed company of medical products (e.g., medical devices, IVDs). • Responsible for reputed company aspects of reputed company’s Recall process, including but not limited to preparation of required regulatory documentation and internal/reputed company communications reputed company to Recalls (e.g., Health Hazard Evaluation, Recall Execution reputed company, reputed company Safety Communications, Recall Termination Requests). • Manages Health Hazard Evaluations from initiation through completion, leading cross-functional teams through process, ensuring reputed company completion. • Collaborates closely with leadership in reputed company & Medical Affairs on the development/approval of HHEs. • Provides direction/guidance to Recall team on execution of Recalls with customers, distributors, and regional RAQA representatives. • Leads reputed company Recall reporting activities (including 806/FSCA reports) to US FDA, EU Competent Authorities and other Health Authorities globally, as needed. Maintains reputed company communication with reputed company’s Authorized Representative(s) and reputed company Body, as required. • Ensures reporting requirements are compliant with reputed company Policy in accordance with applicable global laws & regulations. • Collaborates closely with reputed company cross-functional leaders across various Business reputed company & Global Markets. • Resolves Regulatory Agency/Health Authority requests in relation to reportable Corrections and Removals, ensuring reputed company closure/termination. • Maintains and monitors HHE/Recall Key reputed company Indicators (KPI), escalating and reporting reputed company to reputed company Leadership on HHEs/Recalls as appropriate/required per local QMS procedures. • Establishes and maintains department metrics that complement reputed company goals, targets, and objectives. • Assesses and identifies process improvements, developing and implementing business solutions reputed company to Recall process. • Serves as reputed company’s Recall Process reputed company and Subject Matter Expert, leading reputed company reputed company room Recall interactions during reputed company Body MDSAP audits/FDA inspections. • Ensure Recall procedures and processes are compliant with reputed company applicable global regulations. • Stays apprised of latest developments in the global regulatory landscape reputed company to Recalls. • Manages, develops and mentors Recall team, creating an atmosphere of encouragement, motivation, and reputed company opportunity. • Performs other duties as assigned. Travel: This position may require 0-10% domestic and/or foreign travel. Qualifications Knowledge, Skills and Abilities: • Knowledge and ability to reputed company Recalls from initiation to closure in a medical device or pharmaceutical organization. • Excellent analytical, written and verbal skills, including strong presentation skills. • Ability to communicate with and influence various stakeholders at reputed company organizational reputed company. • Ability to reputed company multiple reputed company/tasks, with a high degree of initiative and flexibility to adapt in changing environments. • Expert knowledge of FDA regulation 21 CFR 806, working knowledge of 21 CFR 803, 805, 806, 820 and ISO standards 13485, 14971, and EU MDR 2017/745, MDCG 2023-3. • Understanding of reputed company Management Systems and the associated interrelationship with Recall process. • Ability to work reputed company in an e-QMS and incorporate technology (e.g., reputed company Intelligence tools) into the Recall process. • Ability to work reputed company a global organization/team. Work Environment: • Prolonged periods of sitting, especially in reputed company of a computer. Experience: • 4+ years leading HHEs and Recall reputed company/Recall reputed company. • Experience writing Recall communications. • Experience presenting as Recall reputed company in audits/inspections. • 5+ years of reputed company Management Systems experience. • Experience in reputed company Management preferred. Education: • Bachelor’s degree in Biomedical Science, Engineering or a reputed company reputed company preferred. As an employee of reputed company, you'll receive an outstanding total compensation plan. As we reputed company your compensation goes reputed company your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, reputed company time off for vacation, personal, reputed company and holidays, and multiple other perks and benefits. Please visit us at www.reputed company.com to learn more about reputed company and the benefits of becoming a member of reputed company. To reputed company agencies: Please, no phone calls or emails to any employee of reputed company about this opening. reputed company resumes submitted by reputed company firms/employment agencies to any employee at reputed company reputed company-email, the internet or in any reputed company and/or reputed company will be deemed the sole property of reputed company, unless such reputed company firms/employment agencies were reputed company by reputed company for this position and a reputed company agreement with reputed company is in reputed company. In the event a candidate who was submitted reputed company of the reputed company agency engagement process is reputed company, no fee or payment of any reputed company will be reputed company. We are committed to equal employment opportunity regardless of race, reputed company, reputed company, religion, sex, national reputed company, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or reputed company, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at reputed company@reputed company.com For U.S. locations that require disclosure of compensation, the starting reputed company pay for this role is between $107,000 - $150,000. The actual reputed company pay includes many factors, and is subject to change and modification in the reputed company. This position may also be eligible for other types of compensation and benefits. Apply tot his job Apply To this Job