Sr Spec, PMS EMEA

Medolla, Modena; Camurana; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading organ therapy company is seeking a Quality Control professional to manage complaint handling and compliance oversight. The ideal candidate will have a science degree, 2–5 years of experience in Quality Control, and must be fluent in English. This role entails maintaining high standards of documentation and regulatory adherence, ensuring effective communication and analytical skills are applied in a fast-paced, regulated environment.

Competenze

• 2–5 years of relevant experience in Quality Control and/or Quality Assurance.
• Ability to work under tight timelines in a highly regulated environment.
• Ability to work both independently and as part of a team.

Mansioni

• Gather complaint information from reporter.
• Ensure consistency of complaint records & proper documentation.
• Assess complaint information to determine regulatory reportability.

Conoscenze

Fluency in English (both written and spoken)

Excellent communication and interpersonal skills

Strong attention to detail

Analytical mindset

Problem-solving and critical-thinking skills

Formazione

Bachelor’s degree or higher (Science field preferred)

Strumenti

Microsoft Office Suite (Excel, Word, PowerPoint, Outlook)

Descrizione del lavoro

Overview

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Responsibilities

• Gather complaint information from reporter (examples: performing due diligence, facilitating sample retrieval, etc);
• Ensure consistency of complaint records & proper documentation (Good Documentation Practices);
• Assess complaint information to determine regulatory reportability as per procedures & regulations;
• Work with plant quality organizations, technical services and/or suppliers to coordinate complaint investigations;
• Maintain compliance to regulations and procedures;
• Work on Post Market Surveillance requirements as part of the EU Medical Device Regulations, including but not limited to:
• Post Market Surveillance Plans;
• Post Market Surveillance Reports;
• Periodic Safety Update Reports (PSURs);
• Clinical Evaluation Reports (CERs)
• Ensure any emerging trends from the field or other PMS data are highlighted and reported to relevant management in real time.
• Ensure accurate and detailed documentation of complaint information.
• Stay informed about applicable regulations and guidelines related to vigilance reporting.
• Initiate and complete vigilance reports within regulatory timelines.
• Maintain a comprehensive database of vigilance reports for internal tracking.
• Provide training to team members on new processes and updates.

Requirements & Qualifications

• Bachelor’s degree or higher (Science field preferred)
• 2–5 years of relevant experience in Quality Control and/or Quality Assurance
• Fluency in English (both written and spoken)
• Based in or willing to relocate to Gurgaon, India
• Excellent communication and interpersonal skills
• Strong proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook)
• Ability to work under tight timelines in a highly regulated environment
• Strong attention to detail and analytical mindset
• Ability to work both independently and as part of a team
• Demonstrated problem-solving and critical-thinking skills

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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