Medical Device Safety Reviewer (Temporary)

Vantive; São Paulo; Hybrid; BRL 206,000 - 252,000; Full time

Benefits offered by this job

Bonus eligibility

Benefits package

Job summary

Vantive is seeking a Medical Device Safety Reviewer to provide expert medical safety reviews of patient-harm and non-harm complaints involving our medical devices, ensuring accurate interpretation and consistent adverse event assessments.

You will collaborate with clinical and cross-functional teams, maintain current knowledge of the product portfolio, and support regulatory compliance to help safeguard patient safety worldwide.

Qualifications

• Healthcare professional (RN) with US Bachelor’s in nursing or equivalent.
• At least 5 years of medical professional experience (hospital, patient care, or equivalent).
• Preferably knowledge of the renal therapeutic area.
• Ability to work in a cross-functional, multicultural team setting.
• Knowledge of national and international medical device regulations and regulatory guidelines.
• Knowledge of medical aspects of medical device safety, medical device vigilance in pre- and post-market settings.

Responsibilities

• Provide Medical Safety review for individual complaints involving patient harm with the use of Vantive’s medical devices.
• Ensure that appropriate medical interpretation and consistency are applied to medical device related adverse event assessments.
• Provide Medical Safety Review for complaints with no patient harm that need an individual assessment.
• Work with clinical counterparts as needed.
• Be an expert for assigned medical devices, maintain current knowledge of full product portfolio and safety profiles for products.
• Communicate and consult with the different stakeholders, R&D, Quality, Regulatory.
• Support internal and external customers regarding evaluation of medical device safety issues.

Skills

Cross-functional teamwork

Regulatory knowledge

Medical device safety

Medical device vigilance

Education

RN preferred

Bachelor’s degree in nursing or equivalent

Job description

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.

The Medical Device Safety Reviewer provides medical safety reviews of medical device complaints, ensuring appropriate medical interpretation and consistency in adverse event assessments. This role serves as a subject matter expert for assigned medical devices, collaborates with clinical and cross-functional stakeholders, and supports the evaluation of medical device safety issues to help ensure patient safety and regulatory compliance.

Essential Duties and Responsibilities

• Provide Medical Safety review for individual complaints involving patient harm with the use of Vantive’s medical devices
• Ensure that appropriate medical interpretation and consistency are applied to medical device related adverse event assessments.
• Provide Medical Safety Review for complaints with no patient harm that need an individual assessment
• Work with clinical counterparts as needed
• Be an expert for assigned medical devices, maintain current knowledge of full product portfolio and safety profiles for products.
• Communicate and consult with the different stakeholders, R&D, Quality, Regulatory...
• Support internal and external customers regarding evaluation of medical device safety issues

Education/Experience

• Healthcare professional (RN,) preferably with a Bachelor’s degree in nursing (US only) or equivalent.
• At least 5 years of medical professional experience (hospital, patient care, or equivalent experience),
• Preferably knowledge of the renal therapeutic area
• Ability to work in a cross-functional, multicultural team setting.
• Knowledge and understanding of national and international medical device regulations and regulatory guidelines.
• Knowledge of medical aspects of medical device safety, medical device vigilance in pre- and post-market settings.

At Vantive, we are committed to fair and transparent pay practices and to creating an environment where people feel valued and supported. We know that compensation matters when considering a new role.

The minimum annual base salary for this position is €40,800. Your starting salary may be higher, depending on factors such as your skills, experience, qualifications, and the unique perspective you would bring to the role.

We carefully consider each candidate individually while also ensuring fairness and consistency across our organization.

In addition to base pay, this position may be eligible for a competitive (bonus and) benefits package designed to support your well-being, professional growth, and life beyond work.

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