Johnson & Johnson Careers

Principle, Regulatory Compliance Manager

Zuchwil, Switzerland
Regulatory Compliance


Job Description

Requisition ID: 1905753520W

"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.


DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world.


As the Principle, Regulatory Compliance Manager you serve as the Johnson & Johnson Medical Devices (JJMD) compliance representative for the External Strategic Collaborator (ESC). You will ensure that appropriate compliance communication channels are established and maintained between JJMD and ESC. You will oversee site compliance activities and ensure an effective business wide compliance program that meets requirements with potential impact to JJMD products. You will also ensure that the Quality System (QS) is in compliance with the established QS requirements and Quality Agreement and determine the effectiveness of the Quality System through compliance programs.


You have 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 effective Internal Audit process, site inspection readiness and overall compliance support and guidance.


There are two positions currently available.


Responsibilities

  • You will be responsible for inspection readiness including inspection response & subsequent follow up as well as inspection management which will provide you the opportunity to show your follow up dedication
  • You will also be responsible for readiness planning / transition for significant changes in Regulations (EuMDR, MDSAP)
  • Takes ownership and handles escalations to ensure effective investigation and identification of issues
  • Compliance metrics collection, trending and reporting
  • Establishes appropriate management tools for the improvement of the department processes, according to the close follow up and improvement opportunities identification.
  • Lead Field Action Assessments
  • Perform joint supplier Reviews
  • Partner and Support Supplier Quality Programs
  • Change Control management
  • Notified Body change management / Notification
  • Management of External Standards and Regulations site support
  • Purchasing control assessments

Qualifications
  • University/Bachelor Degree or Equivalent is required
  • Requires five (6+) years of related experience in areas such as Quality Operations, Compliance, Quality Systems, Quality Management, Design Quality, etc. is required
  • Three (4+) years of supervisory experience (preferred)
  • Experience supporting External Health Authority and Regulatory Body Inspection is required
  • Requires five (6+) years of related experience in areas such as Quality Operations, Compliance, Quality Systems, Quality Management, Design Quality, etc. is required
  • Three (4+) years of supervisory experience (preferred)
  • Experience supporting External Health Authority and Regulatory Body Inspection is required
  • Stakeholder management and relationship building skills
  • Proven leadership and management skills
  • Excellent communication and interpersonal relation skills
  • Advanced Quality Systems knowledge
  • Interpretation and application of QSR, ISO Standards and other relevant global regulations
  • Strong coaching skills and the ability to influence

Primary Location
Switzerland-Solothurn-Zuchwil-
Organization
Synthes GmbH (7111)
Job Function
Regulatory Compliance
Requisition ID
1905753520W