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Director Customer Quality, AIRs and Emerging Issues
Location:
Westborough, MA
Description:
Working Location:MASSACHUSETTS, WESTBOROUGH; CALIFORNIA, SAN JOSE; PENNSYLVANIA, CENTER VALLEY Workplace Flexibility:Field Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together. Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years. Our Purpose is to make people's lives healthier, safer, and more fulfilling. Our Core Values are reflected in all we do: Integrity : Empathy : Agility : Unity : Long:Term View We deliver on our purpose and our core values by staying True to Life. **Please note: All correspondence will be sent from our Olympus domain ( ). If you receive correspondence from an entity other than , it is likely not legitimate. Job Description: Leads and directs cross:functional team to document responses to requests for additional information from regulators ensuring communicationsadhere the Global Quality System and applicable regulatory requirements.: Responsible for reviewing complaint handling requests for additional information and other post market responses prior to submission to regulators.: Develops a global post market regulator communication process including tracking and trending of responses to regulators.: Provides guidance, training, coaching to team quality compliance matters including on communication with regulatory agencies regarding post market issues.: Gathers, maintains, and distributes Emerging Issues communications to internal stakeholders .: Identifies issues that require escalation to leadership, and potential issues for consideration for risk assessment or Health Hazard Assessment Job Duties: Develops and implements the global regulatory requests for additional information communication process and activities.: Responsible for the completion of regulator requests for additional information to the US FDA, and other Regulatory Authorities as applicable.: Leads cross functional teams on investigating, assessing and authoring responses.: Tracks, trends, and analyzes requests for additional information from regulators, respective corrective actions, and remediations; provide inputs to upstream processes for improvements.: Gathers, collates, and maintains Emerging Issues report; distributes and presents to internal stakeholders.: Identifies issues that require prompt notification and presents/communicates to Olympus senior leadership in a clear and concise manner.: Escalates potential safety issues for risk assessment or health hazard assessment.: o Manages the development of Global Hot Topic communications.: o Works together with the Customer Quality organization to identify, access, and analyze data that have impact on the company's compliance with overall quality systems.: Apply sound, systematic problem:solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.: Advise management on potential improvements or enhancement to quality systems and processes in the company.: Develops new approaches to solve problems identified as part of the team.: Participates in the implementation of Global Customer Quality initiatives and programs throughout the Global organization, as required.: Participates in the CAPA process as required as an assignee or project team member. Job Qualifications Required: : Bachelor's degree in a science, engineering discipline, or equivalent: A minimum of 15 years of related professional experience in the medical device industry.: A minimum of 5 years managing direct or indirect teams in the medical device environment.: Experience developing and managing communications to regulatory agencies.: Experience working with, presenting to and communicating with executive leadership.: Requires background and familiarity with applicable
Posted:
July 3 on Tip Top Job
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More About this Listing: Director Customer Quality, AIRs and Emerging Issues
Director Customer Quality, AIRs and Emerging Issues is a Executive Director Job located in Westborough MA. Find other listings like Director Customer Quality, AIRs and Emerging Issues by searching Oodle for Executive Director Jobs.
Director Customer Quality, AIRs and Emerging Issues is a Executive Director Job located in Westborough MA. Find other listings like Director Customer Quality, AIRs and Emerging Issues by searching Oodle for Executive Director Jobs.