Johnson & Johnson Careers

Sr Regulatory Compliance Specialist

Raynham, Massachusetts
Regulatory Compliance


Job Description

Requisition ID: 2016180522

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world is recruiting for a Sr Regulatory Compliance Specialist located in Raynham, MA. 


DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own. 

 

The Senior Compliance Specialist, DePuy Synthes ensures effective business wide compliance program that meets requirements for the medical device business. This position will partner with Compliance leaders globally to ensure efficient Internal Audit process, site inspection readiness and overall compliance support and guidance.  This individual will collaborate with all levels, building partnerships to further DePuy Synthes in the refinement of short and long-term compliance objectives.  This position is a part of the Regulatory Compliance team of DePuy Synthes. This role provides Compliance support to the assigned site(s).

The Compliance Specialist will:
  • Direct and/or conduct internal and external audits against US FDA Quality System Regulations, ISO, and Heath Authority Regulations from other countries in which DePuy Synthes markets products (e.g. Canada, Australia, Brazil, Japan and China)
  • Coordinate and lead, in collaboration with Quality leaders, site audit readiness activities
  • Provide audit results to management and coordinate audit CAPA / Observation actions
  • Conduct personnel training on EtQ Audit Software Application use
  • Direct and/or conduct investigations into potential quality / compliance concerns.  Keep management informed of issues.
  • Stay current on applicable FDA, ISO (including risk management) and other applicable industry requirements.


Qualifications
  • Bachelor’s degree in science, engineering, quality or another technical field is required
  • Minimum of 5 years quality / compliance experience in the medical device and/or pharmaceutical industries is required
  • A minimum of 3 years’ experience in a quality and/or compliance function is required
  • Experience leading internal audits is required
  • Experience supporting External Health Authority and Regulatory Body Inspection is required
  • Auditor Certification, such as ASQ CQA, is preferred; minimum of auditor training required
  • Documented training in FDA Quality System Regulation, ISO 13485, MHLW Ordinance 169, RDC ANVISA 16 and Therapeutic Goods (Medical Device) Regulations.
  • A minimum of 10% domestic travel is required
 

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.



Primary Location
United States-Massachusetts-Raynham
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Regulatory Compliance
Requisition ID
2016180522