Pam Rocksted Email & Phone Number

Indianapolis, IN 46240

• 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.

Westminster, Colorado

Monroeville, PA 15146

• 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.

Westminster, Colorado

Huntington Beach, California

Overland Park, Kansas

Denver, Colorado

Denver, Colorado

Jacksonville, Florida

Jacksonville, Florida

Lymphedema Therapy Certification

Wound, Ostomy, Continence Nurse Certification

Bachelor Of Science (Bs)