Role details

Vigilance Reporting Coordinator

Vaud   •  Permanent

Bullet points

  • Vigilance
  • Medical Devices/ Pharmaceuticals

About Our Client

Our client is an innovative company in the medical equipment industry expanding its EMEA headquarter based in Switzerland.

Job Description

Main activities

  • Evaluate and report device malfunctions and adverse events involving company products to determine Medical Device vigilance reporting eligibility to the European regulatory agencies
  • Ensure complete, accurate and timely reporting of vigilance data as required by regulatory agencies
  • Evaluate incoming field reports, product returns and product analysis results for company products as necessary to determine vigilance reporting
  • Perform detailed investigation of adverse events by contacting internal resources, field personnel and/or customers as appropriate. Generate medical device rationale or vigilance report for all products complaints
  • Conduct follow up investigations for reported events and assist in data collection for trending purposes
  • Prepare correspondence for European regulatory agencies requests and support inspections and audits
  • Develop and maintain integrated system post market safety reports for devices
  • Provide input on internal system and methods to maintain vigilance compliance and support post-market surveillance
  • Respond in a timely manner to requests for additional information from regulatory agencies

Additional activities

  • Implements and supports Quality Management System activities such as CAPA, documentation, training, management review, internal & external audits, Field Safety Corrective Actions
  • Ensures that company procedures, processes and documentation meet the required guidelines for maintaining compliance to the Quality Management System, ISO 13485 and other applicable regulations
  • Acts independently to determine and coordinate methods and procedures on new assignments and works in teams to install or improve related processes
  • Assists and supports other employees, teams and field personnel as necessary
  • Other regulatory tasks and projects may be assigned as necessary

The Successful Applicant

Required Knowledge, Skills, and Experience:

  • A Bachelors or Master's degree in healthcare, health sciences, medical technology, biomedical engineering or related field
  • 2+ years of significant experience with Vigilance reporting in the medical device (preferred) or Pharma industry is a must
  • Strong knowledge of the European Medical Device Directive 93/42/EEC and MEDDEV 2.12-1
  • Knowledge of appropriate global medical device regulations, requirements, and standards, such as ISO13485 or ISO14971
  • Ability to work autonomously and exercise daily judgement based on above regulatory knowledge.
  • Demonstrated organizational and planning skills, including action oriented, focused urgency and driving for results
  • Ability to contribute in complex projects despite ambiguity and/or rapid change
  • Ability to handle multiple tasks and to prioritize and schedule work to meet business needs
  • Good interpersonal skills, ability to work with others in team environment; effective interactions in cross department teams
  • Excellent communication skills, over the telephone, in person, and in writing.
  • Orientation for work result details, with emphasis on accuracy and completeness
  • Fluent in written and spoken English, ideally possessing other language skills such as German
  • Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook), experience with ERP / CRM software such as SAP a plus

What's on Offer

Great opportunity to join an innovative company with strong international exposure.

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