Compliance Manager

hace 2 semanas

Ciudad Juarez, México Johnson & Johnson A tiempo completo

At **Johnson & Johnson **, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer healthier lives.In a radically changing environment, we are making connections across science and technology to combine our expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.We are in this for life.We are changing the trajectory of human health, YOU CAN TOO.**We are searching for the best talent for Compliance Manager to be in Juarez.****Purpose**:- The SourceRegulatory Compliance Manager serves as the Johnson & Johnson Medical Devices (JJMD) compliance representative for the External Strategic Collaborator (ESC).- He/she ensures that appropriate compliance communication channels are established and maintained between JJMD and ESC.- This individual will oversee site compliance activities and ensures effective business wide compliance program that meets requirements with potential impact to JJMD products.- He/she will ensure that the Quality System (QS) is in compliance withthe established QS requirements and Quality Agreement and determines the effectiveness of the Quality System through compliance programs.- He/she has the necessary independence, authority and responsibility to communicate compliance problems according to the J&J escalation standard and Quality Agreement.- This position will partner with JJMD Compliance leaders and ESC Quality Operations & Compliance to ensure,site inspection readiness and overall compliance support and guidance**You will be responsible for**:- Inspection readiness-Inspection response & subsequent follow up -Inspection management- Commitment follow up-Readiness planning / transition for significant changes in Regulations (EUMDR, MDSAP)- Escalations-Compliance metrics collection, trending and reporting- EMSAFollow up-Field Action Assessments- Joint Quality Review- Partner and Support SupplierQuality Program**Qualifications**:- University/Bachelor Degree or Equivalent is required- Requires five (5+) years of related experience in areas such as Quality Operations, Compliance, Quality Systems, Quality Management, Design Quality, etc. is required.- Three (3+) years of supervisory experience (preferred)- Experience supporting External Health Authority and Regulatory Body Inspection is required- Stakeholder management- Leadership and management skills- Excellent communication and interpersonal relation skills- Regulatory compliance knowledge and skills- Advanced Quality Systems knowledge- Coaching skills

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