Senior Quality and Regulatory Management Specialist, Commercial APA (India, Middle East, Africa)
Eppendorf
Chennai, Tamil Nadu
Permanent
Full-time
1 month ago
Your challengesImplement and improve a standardized and manageable Multisite Commercial QM System for your market, which will reduce the complexity and duplication of activities across Sales and Service Organizations while building capabilities toEnsure compliance to enable growth.Drive continuous improvement and deployment.Focus on prevention action and customer satisfaction.Manage the design of end-to-end quality processes and tools to achieve highest customer satisfaction.Drive process harmonization and standardization within your market in alignment with Corporate QMBe Management Representative for your market (according to local QM System)Be first contact partner for the complaint management process for your market.Ensure correctness of complaint data entry for your marketLiase with Eppendorf SE in case of adverse event reporting and field safety corrective actionOverview and support all RA aspects as needed, incl. required registrations and certifications.Gather, analyze, assess, and communicate regulatory requirements and be internal and external contact point for market-related regulatory inquiries for your market.Liase with Corporate RA and R&D RA to identify market requirements and for submission in your market.Lead development and roll out of QM, PMS, and RA KPIs for area and processes of responsibility.Implement and maintain the effectiveness of the Multisite Commercial QM System and ensure compliance with applicable standards for your market.Define, design, and utilize QM practices and tools.Implement and improve quality processes in alignment with Corporate QMDesign end-to-end processes as imitative leader.Organize and conduct document control, change management, management review, audit, nonconformance, and CAPA management.Provide QM related trainings within your market.Represent your market as Management RepresentativeCommunication and first contact partner for the complaint management processReview uniformity of complaint registrations, incl. data cleaning and correction (Quality Review)Conduct with complaint classification trainings to support training, mentoring, and continuous improvement.Monitor local adverse event reporting, and field safety corrective action.Represent your market towards notified bodies and regulatory authorities.Proactively screen for new and relevant local regulatory requirements and standards for India, Middle East, Africa.Assess local regulatory requirements and provide information for Eppendorf impact.Liase with Corporate RA and R&D RA to identify market requirements for submission.Process QM/RA related customer inquiries.Build KPIs and monitor QM, PMS, and RA KPIs, thereby collect data and provide reports.Support other QMRA colleagues in the region as required.Your expertiseDeep knowledge in Regulatory Submission processes within India, Middle East, Africa regionDeep knowledge in Q-Systems ISO 9001, 17025At least 3 years of experience in the Life Science or Medical Device industryDegree in natural sciences or comparable scientific or technical education.Excellent English language and communication skills.Additional language skills related to the relevant markets desirable.Strong intercultural competence and experience in working with Asian and European/Western organizations.Experience in cross functional working in a matrix organization.Your benefits at EppendorfWe truly appreciate our employees and their performance. This is why we offer an attractive salary.By working with us, you will make a meaningful contribution to improving human living conditions.To enable you to depend on your technical knowledge and to continuous development, we offer a wide range of training and development options.Attractive employee benefits.Attractive performance bonus.
