Cypress HCM · 2 hours ago
Product Safety and Vigilance Specialist
United States
Contract
Remote
Mid Level
$65/hr - $67.30/hr
3+ years expCypress HCM is a growing global company in the medical equipment industry, and they are seeking a Product Safety and Vigilance Specialist. The role involves identifying and assessing product safety risks, ensuring compliance with regulatory standards, and communicating with stakeholders regarding medical device reporting and complaint management.
Human ResourcesInformation TechnologyStaffing Agency
Hiring Manager
Brianna Fugere
Responsibilities
Participates in the investigation and assessment of potentially reportable events:
Gathers, reviews, and analyzes data and documentation, performing product surveillance within North America for potential corrective action and continued improvement/product excellence
Reviews, evaluates, and interviews appropriate people regarding product complaints relative to the identity, quality, safety, and effectiveness of medical devices
Tracks and reports on all stages of the investigation process including data analysis, reporting, documentation review, coordination of complaints, device history reviews, compliance, and review and closure of complaints
Assist with upstream and/or downstream processes to obtain additional information:
Coordinates activities required for investigations, including failure analysis, nonconformance, and corrective and preventive action (CAPA), working with Engineering, Manufacturing, and Quality Assurance
Ensure complete and consistent documentation of vigilance cases with timely processing to final closure:
Documents the analysis of product complaints for trends and identification of potential corrective or preventive actions
Reviews and analyzes documentation and determines root cause or if there are any irregularities that may have related to reported product failures. Evaluates and determines risk of product failure
Develops proactive internal and regulatory risk minimization action plans for real and theoretical risks. Utilizes understanding of the scientific basis for diseases, adverse events, and knowledge of risk management tools to assess benefit versus risk
Participates in multi-site product safety teams and Field Safety Corrective Actions:
Supports the developing of project plans and contributes to completion of milestones associated with specific product safety teams and FSCAs
Communicates with authorities and regulatory agencies on reported cases and market actions:
Assists during FDA, ISO, or other third-party audits and implements or assists in implementing corrective and preventive actions
Qualification
Required
3-5 years' experience in a highly regulated environment - preferably medical device/pharma industries
Strong PC skills (MS Office, SAP/R3)
High communication and conflict resolution skills
4 year-degree or commensurate experience may be substituted for degree requirement
Preferred
Experience in Quality, Product Safety, Product Surveillance or Vigilance
Completion of commercial training or medical training as a health care professional with administrative experience
Company
Cypress HCM
Cypress HCM is a staffing and recruiting company providing technology and creative recruiting solutions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Mark Lillig
CEO
Philip Oommen
CFO
Company data provided by crunchbase