Principal Specialist Regulatory Affairs

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.

Summary

Responsible for support to CE marking activities (MDD 93/42/EEC and MDR 2017/745) for medical devices from all Vantive legal manufacturers with emphasis on regulatory compliance and life cycle strategy.

Essential Duties and Responsibilities

•Supports Vantive Legal Manufacturers in the fulfilment of regulatory responsibilities under the MDD and MDR.
•Provides direction to all Vantive legal manufacturers with regards to CE marking requirements.
•Interprets existing, pending and proposed regulations/guidance documents regarding MDD, MDR providing assessment on impact to Vantive.
•Works with cross-functional groups to ensure the development of regulatory strategies for the CE marking Medical Devices in accordance with the business goals.
•Collaborates with relevant teams to meet regulatory requirements related with data necessary for regulatory databases.
•Supports the implementation of the Regulatory Affairs management systems (including relevant SOPs) to ensure the regulatory requirements are met.
•Participate in regional Industry Association meetings (including MedTech EU working groups).
•Leads CE marking related regulatory activities in front of the Notified Bodies and relevant Competent Authorities.
•Maintains compliance with regulatory requirements and internal policies and coordinates regulatory compliance activities.

Qualifications

•Around 3-5 years of experience preferably in Regulatory Affairs, Quality Assurance R&D or System, Standard Compliance testing in a Medtech company/ Notified Body or Regulatory Authority.

•Good knowledge of CE marking of medical devices (MDD 93/42/EEC, MDR 2017/745 and related directives and guidelines).
•Ability to interpret European regulations and guidelines and all technical product information in order to assure that regulatory requirements in the area of medical devices are continuously met.
•Ability to liaise with the different functions involved in the elaboration of CE files, Manufacturing, Quality Assurance, R&D, Medical Affairs, Logistics.
•Excellent interpersonal and collaboration skills and willingness to work in a challenging regulatory environment.
•Excellent organizational skills including project management skills.
•Strong commitment to teamwork, quality and customer satisfaction.
•Excellent written and verbal communication skills in English.
•Cultural sensitivity.
•Accountable for anticipating and resolving problems.
•Open to innovation and risk taking.

Education and/or Experience

Degree in engineering or life sciences

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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