Vigilance Reporting Coordinator
- 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
- 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
Medical Devices/ Pharmaceuticals
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
Our client is an innovative company in the medical equipment industry expanding its EMEA headquarter based in Switzerland.
Great opportunity to join an innovative company with strong international exposure.