Customer Quality Regulatory Specialist II in West Chester, Pennsylvania | DiversityInc Careers
 
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Customer Quality Regulatory Specialist II


DePuy Synthes Companies of Johnson & Johnson is seeking a Customer Quality Regulatory Specialist II located in West Chester, PA.

 

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. 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.

 

Customer Quality Regulatory Specialist II is a member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include the submission of Health Authority Reporting and follow-up responses.  The Customer Quality Regulatory Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts.  This individual is familiar regarding regulations and standards affecting Medical Devices (e.g. ISO9001/13485/14971/14001, FDA Regulations (21CFR (803, 806, 820, part 11, etc.)), CMDR, and Medical Devices Directive (93/42/eec, 98/79/EC)).

 

DUTIES:

  • Prepares and submits Medical Device and/or Health Authority Reports within the required timelines.
  • Responsible and accountable for the accuracy of submitted regulatory reports.
  • Prioritizes work according to needs of department to support regulatory reporting and complaint investigation timeliness.
  • Responds to regulatory requests within requested timeframes.
  • Assists in the review of daily reports
  • Interacts with related agencies as requested.
  • Familiarity with applicable regulations for reporting.
  • Interacts positively with internal/external business partners and colleagues.
  • Adheres and complies to work instructions, standard operating procedures, and regulations.
  • Participates in tracking metrics for department.
  • Achieves productivity targets.
  • Participates in CAPA/NC/DR activities and can act as task owner as required.
  • Assists with assignments of activities to meet deadlines.
  • Maintains current training records.
  • Proactive collaboration and resolution to cross-functional issues with stakeholders.
  • Participates in interview process for selection of new hires.
  • All other duties as assigned by management.


Qualifications

  • A Bachelor’s Degree is required
  • A minimum of 2 years of experience in a GMP and/or ISO regulated industry is required
  • RAC or ASQ certifications a plus
  • Ability to work in a cross-functional and matrix environment is required
  • Requires organizational and critical thinking skills is required
  • Ability to prioritize and multi task is required
  • Ability to respond to the urgent needs of the team, with proven track record of meeting deadlines is required.
  • Problem solving/Root cause analysis skills are required
  • Strong verbal and written communication skills are required
  • Knowledge of basic medical terminology is preferred
  • Proficient in MS Office (Word, Excel, Outlook, PowerPoint, SharePoint) is required
  • Global mindset is preferred
  • Ability to interface with technical and non-technical personnel at all organization levels is preferred.

This position will be based in West Chester, PA and will require up to 10% travel.

 

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-Pennsylvania-West Chester
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality Assurance
Requisition ID
9008180807