EU Senior Post Market Surveillance Specialist

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

Primary Function of Position:

The Post Market Surveillance Sr. Analyst supports the Regulatory Department by reviewing, evaluating, and performing follow up activities on all product complaints, determining if they require vigilance reporting, identifying supporting data, notifying regulatory agencies and responding to their requests related to vigilance reporting as necessary.

Roles & Responsibilities:

Main activities

• Evaluates and reports device malfunctions and adverse events involving company products to the European competent authorities
• Responds to European competent authorities requests related to vigilance reporting
• Collect, trend and escalate data related to Post Market Surveillance
• Independently advises cross-functional teams on vigilance reporting requirements
• Support training of new team members
• Acts as an interface between EMEIA customer support team, Regulatory Post Market Surveillance team in US and European customers, including distributors;

Additional activities

• Evaluates incoming complaint information and maintains the records in the electronic database as per company procedures and processes. Works closely with Customer Service to support the product return process as it relates to complaints.
• Processes, records and closes complaints 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 per regulatory reporting requirements
• Support Quality Management system activities such as CAPA, Field Safety Corrective Actions, documentation, training, management review and internal & external audits as needed
• Assists and supports other employees, teams and field personnel as necessary
• Other regulatory tasks and projects may be assigned as necessary

Skills, Experience, Education, & Training:

Required Knowledge, skills and Experience

• In-depth knowledge and understanding of the European Medical Device Directive 93/43/EEC, MEDDEV 2.12-1 and EU Medical Device Regulation EU/2017/745
• In-depth knowledge of quality records requirements and how they apply to complaint files and post market surveillance reports.
• A Bachelor’s degree or Swiss CFC (Health sciences preferred)
• 2-3 years of experience in Post Market Surveillance for medical devices
• Ability to handle multiple tasks, to prioritize and schedule work to meet business needs
• Demonstrate organizational and planning skills, including action oriented; focus urgency and driving for results.
• Good problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations
• Demonstrate good communication skills, over the phone, in person and in writing.
• Demonstrate good interpersonal skills, ability to work with others in international team environment, effective interactions in cross department teams.
• Ability to guide customers in providing key relevant data for case management
• Orientation for work result details, with emphasis on accuracy and completeness
• Fluent (C1 minimum) in written and spoken English and at least another European language (French or German preferred)
• General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)

Preferred Knowledge, Skills, and Experience:

• 3 – 5 years of experience in a Medical Device environment
• US FDA 21 CFR 803/806/820 knowledge would be a plus.
• Ideally possessing other third language skills for the European market
• Experience with softwares such as TrackWise, ERP / CRM (eg. SAP) or Salesforce is a plus.

Shift :Shift 1 - Day

Travel :No