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Prof III-Regulatory Affairs-General Regulatory Affairs

4 months ago

Plymouth, United States Baxter Full time

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Scope of the Position:

  • All regulatory aspects for assigned medical devices with emphasis on global regulatory / compliance and life cycle maintenance (including labeling content ownership and change control impact assessment responsibilities) with direct responsibility for medical devices from the Acute Therapies global business unit.
  • Preparation of relevant global registration files like STED, design dossiers or technical files (e.g. variation or renewal files), in close collaboration with the different functions involved.
  • Contacts with the relevant Regulatory Authorities involved in the relevant medical devices and for the resolution of any questions coming from the authorities during licensure and life cycle maintenance of such devices.
  • Support of regional/global requests related to the supported global product families when connected to regulatory requirements, directives and guidelines.

Primary Responsibilities

Strategic Planning and Problem Solving:

  • Collaborate with global regulatory counterparts to develop global / regional / country regulatory strategy.
    • Participate in the development and implementation of business unit strategy to ensure regulatory viability of strategic business initiatives.
    • Identify priorities and key issues in complex situations, and solves these problems with minimal assistance.

Scientific / Technical Analysis:

  • Provide guidance to project teams in design and analysis for more straight forward projects.
  • Understand and identify potential flaws and implications and coach the team on tradeoff decisions.
  • Conversant and able to influence (colleagues, study designers, and Regulators) in multiple scientific areas.
  • Understands and is conversant with respect to safety, efficacy and performance profile of their products.
  • Negotiate with Regulators (e.g., MoHs, Notified Body/ies} on multiple projects on matters involving data requirements and study design to ensure approval.

Product/Process Quality Standards:

  • Educate internal stakeholders on implications of regulations.
  • Develop procedures in regulatory compliance matters.
  • Understand external regulatory policy and industry standards and communicate impact to projects and provide direction to R&D teams.

Communication with Regulators / Customers / MoH's:

  • Plan, coordinate, prepare, and execute formal meetings with regulatory agencies on complex and strategic programs (e.g. meetings with Notified Body experts on specific reviews like Animal Origin or biocompatibility).
  • Proactively interact and negotiate with regulatory agency project review teams to ensure positive outcomes for submission.
  • Proactively build and manage relationships with Regulators.

Submission / Project Management:

  • Lead the preparation, planning, coordination, execution; and ongoing maintenance of regulatory submission.
  • Communicate submission quality standards and requirements to project teams.
  • Serve as the regulatory expert on cross-functional teams to ensure quality dossier.
  • Identify potential risks in submissions and appropriately communicate.
  • Oversee development of submission content, documents and timeline for complex projects.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

Reasonable Accommodations

Baxter 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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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