Pam Rocksted

Experience

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  Vistakon/Johnson & Johnson

  Jan 1991 - Jan 1993

  Medical Device Consultant
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  Baptist Home Healthcare

  Jan 1994 - Jan 1996

  Clinical Consultant for Wound, Ostomy and Continence Care
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  First American Home Health Care

  Jan 1996 - Jan 1997

  Clinical Consultant for Wound, Ostomy and Continence Care
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  Specialty Nursing Services, Inc.

  Jan 1997 - now

  President/Owner
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  Diabetic Foot and Wound Center

  Jan 1999 - Jan 2000

  Research Coordinator
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  Accredo Clinical Business Solutions

  Jan 2004 - Jan 2012

  Senior Program Specialist
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  Calmoseptine Inc

  Jan 2004 - Jan 2013

  Industry Consultant
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  St. Anthony North Hospital, Catholic Health Initiatives

  Jan 2008 - Jan 2013

  CWOCN, CLT
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  MAETRICS

  Jan 2013 - Jan 2014

  Medical Device Clinical Consultant
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  RQM+

  May 2014 - Jun 2016

  Clinical Consultant, MDR Specialist

  • Coordinate with team to determine if the reported complaint is associated with a malfunction, serious injury or death and whether the complaint documentation is complete and accurate.• Review and evaluate complaints for MDR reporting decisions in accordance with 21CFR 803.• Responsible for conducting review of product quality complaints to gather information, communicate with medical professionals, end users, etc., for MDR determinations.• Determine final reportability of complaints per MDR regulations in accordance with 21 CFR 803 when team is unable to come to a decision.• Responsible for escalating any new, unknown risk or hazards for further evaluation and decisions.• Responsible for documenting reviews of medical evaluations.• Review and evaluation of complaints with new or additional information to determine if the complaint requires MDR reporting and file MDRs as required.• Draft MDRs for submission within 5/30 days of information that necessitates the MDR.• Work with multidisciplinary and cross-functional teams from various business units to ensure the timely completion and closure of reportable complaints. Show less

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  MAETRICS

  Sept 2016 - now

  SME Clinical Consultant

  Highlights of Qualifications• Coordinated with a global, cross-functional team to facilitate timely and accurate assessment of complaints, with specific emphasis in ensuring information was analyzed for determining regulatory reporting requirements.• Generated MDR’s and International Notified Body submissions. • Assessed complaints on-site in Zuchwil, Switzerland, using CATSweb software as the clinical SME of a remediation team.• Provided clinical knowledge of injuries to assist Regulatory Affairs in determining recall requirement, and supported subsequent product recall activities.• Leveraged clinical knowledge and experience to investigate the role of medical devices in reported injuries/deaths.• Provided education on disease states, treatments, and clinical use of devices to regulatory professionals in response to an FDA warning letter.Skills Summary• Root Cause Analysis• Post-Market Surveillance• Remediation• Complaint Handling• Clinical Studies/ Journal Articles• Scientific Literature Review• Critical Clinical Evaluations• GMP Inspection Responses and Recalls- • 483s, Warning Letters & Consent Decrees• Complaint Investigation Compliance- Use of various complaint software programs including EtQ, TrackWise & CATSweb• MDR Submissions/International Notified Body Submissions• Knowledge of FDA QSR regulations -21 CFR 803, 806 & 820• Knowledge of ISO 13485• Product Labeling Review• Clinical Resource/ SME Show less