Intuitive Surgical Careers
Post Market Surveillance Coordinator – Vigilance
Primary Location: Switzerland-Vaud-Aubonne-
Position’s Objective & Summary:
The Post Market Surveillance Coordinator supports the Regulatory Department by reviewing, evaluating, and performing follow up activities on all product complaints, determining if they require vigilance reporting and notifying regulatory agencies as necessary.
Roles & Responsibilities:
- Main activities
- Evaluates incoming complaint information and maintains the records in the electronic database.
- Processes, records and closes complaint-handling activities in a timely manner.
- Conducts follow up investigations with internal resources, field personnel and/or customer as appropriate to gather additional information for reported events and assist in data collection for trending purposes.
- Determines reportability of complaints by liaising with the team who performs technical investigation and who prepares product analysis results for company products.
- Ensures complete, accurate and timely reporting of vigilance data as required by regulatory agencies.
- Prepares and responds to the European regulatory agencies requests for additional information in a timely manner.
- Develops and maintains post market surveillance system.
- 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
- Supports Quality Management System activities such as CAPA, Field Safety Corrective Actions, documentation, training, management review, internal & external audits
- 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
Required Knowledge, Skills, and Experience:
- A Bachelor, Engineering Degree required Master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function), ideally possessing a clinical background
- 2 – 5 years of significant experience in post market surveillance, at least 2 years of experience in vigilance reporting; Medical device industry experience preferred
- Good knowledge of the European Medical Device Directive 93/42/EEC and MEDDEV 2.12-1
- Ability to work autonomously and exercise daily judgment based on above regulatory knowledge.
- Demonstrated organizational and planning skills, including action oriented, focused urgency and driving for results
- Ability to handle multiple tasks and to prioritize and schedule work to meet business needs
- Good interpersonal skills, ability to work with others in international 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 and French
- Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
Preferred Knowledge, Skills, and Experience:
- US FDA 21 CFR 803/806/820 and EU Medical Device Regulation (2017/745/EU) knowledge would be a plus
- Ideally possessing other language skills such as German or other European languages
- Experience with softwares such as TrackWise or Salesforce is a plus