Lead Vigilance and QARA Spain

Insulet Corporation; Ourense; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A healthcare technology company based in Galicia, Spain is seeking a Regulatory Affairs Specialist to ensure compliance with medical device reporting requirements. Responsibilities include serving as the local contact with Spanish authorities, managing vigilance processes, and supporting audits. Candidates should have relevant experience in medical writing and complaint processing, along with a BA/BS degree. Fluency in Spanish and English is essential. This dynamic role involves collaboration across various functions to maintain regulatory compliance.

Formación

• Experience in professional writing in a medical technology or healthcare setting.
• Knowledge of EU MDR 745/2017 and country-specific vigilance regulations.
• Effective verbal and technical writing skills.
• Ability to organize and judge priorities.

Responsabilidades

• Act as the local vigilance contact with the Spanish competent authority.
• Support activities for global vigilance reporting.
• Liaise with external partners regarding vigilance and quality matters.
• Maintain the Vigilance Mailbox and monitor emails.
• Provide support for internal and external audits.

Conocimientos

Regulatory communication

Complaint processing

Technical writing

Attention to detail

Fluent in Spanish and English

Educación

BA/BS degree

Descripción del empleo

Position Overview

Review, analyze, and compose responses to regulatory agencies regarding medical device reportable events and collaborate both within post market surveillance and across other functions, including customer care, quality, clinical and regulatory to help ensure compliance with reporting requirements and good documentation practices. This position reports to the Director EMEA Vigilance and QARA.

Responsibilities

• Act as the local vigilance contact with the Spanish competent authority
• Act as the representative for the regions under their responsibility
• Support activities for global vigilance reporting such as Process, prepare, write and submit RFAI requests from Competent Authorities
• Maintain the Vigilance Mailbox and monitor emails
• Support cases reportability assessment when needed by completing due diligence on additional information requests with the complaint reporter
• Critically interpret results of trending reports, failure investigations/engineering reports and determine how to present the data most effectively in a succinct manner
• Attend/support meetings with the competent authorities
• Liaise with external partners (ex. Distributors) regarding vigilance and quality matters
• Process due diligence requests
• Process investigation results requests
• Collaborate with other functions to compile compliance documentation for post market
• Follow processes and operational policies in selecting methods and techniques for obtaining solutions
• Support regional markets with activities related to product being introduced or currently on the market
• Provide support as needed for internal and external audits/inspections
• Complete administrative verification on product to be distributed on the EU markets as needed
• Act as local Regulatory point of contact in Spain
• Complete regulatory review and validation of material intended for use with third parties in Spain

Education And Experience

• Relevant experience in professional writing in a medical technology, life sciences, or healthcare setting
• Complaint processing experience
• Knowledge of the EU MDR 745/2017 and country specific vigilance related regulations
• BA/BS degree
• Effective verbal and technical writing skills. Ability to communicate at multiple levels of an organization
• Ability to organize and judge priorities
• Ability to assimilate and interpret scientific content, and translate information for appropriate audience in a succinct manner
• Strong attention to detail with excellent grammatical, editorial, and proofreading skills
• Spanish native speaking person, must be fluent in speaking and writing in English

Preferred Skills And Competencies

• Willingness to pursue additional learning and build qualifications in professional field, as required
• Experience leading/managing improvement projects