EU Post Market Surveillance Specialist

Intuitive; Madrid; On-site; EUR 36,000 - 48,000; Full time

Job summary

Intuitive is seeking a Post Market Surveillance Specialist to support the Regulatory Department by reviewing and following up on product complaints. You will determine if reports are required for vigilance and help identify supporting data for regulatory obligations.

In this role you will work with internal teams and international partners to investigate complaints, evaluate reportability, and contribute to post-market data trends and regulatory compliance across EMEIA and US regions.

Qualifications

• Experience with regulatory reporting for medical devices.
• Ability to evaluate complaints and determine reportability.
• Experience coordinating with regulatory teams across regions.

Responsibilities

• Evaluate incoming complaint information and maintain records in the electronic database.
• Process and close complaint-handling activities in a timely manner.
• Conduct follow-up investigations to gather information for trending purposes.

Skills

Regulatory affairs

Complaint handling

Data collection

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Tools

CRM systems

Databases

Job description

Job Description

Primary Function of Position:

The Post Market Surveillance Specialist supports the Regulatory Department by reviewing, evaluating, and performing follow up activities on all product complaints, determining if they require vigilance reporting and identifying supporting data.

Roles and Responsibilities:

Main 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 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 per regulatory reporting requirements.
• Acts as an interface between EMEIA customer support team, Regulatory Post Market Surveillance team in US and European customers, including distributors.

Additional activities

• Evaluates and reports device malfunctions involving company products to the European regulatory agencies.
• Collect, trend, and escalate data related to Post Market Surveillance.
• Assists and supports other employees, teams, and field personnel as necessary.
• Other regulatory tasks and projects may be assigned as necessary.