Regulatory Affairs Specialist
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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.
Regulatory Affairs Specialist is responsible for the development and implementation of global regulatory strategies, obtaining and maintaining marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products. Additionally, providing on-market regulatory support for currently registered global products and expansion of products into new markets.
Duties and Responsibilities
- Global Regulatory Lead for a portfolio of Class II / Class I medical devices marketed worldwide.
- Represent global regulatory affairs and act as a liaison for local country RA on cross-functional project teams
- Ensure regulatory activities are in alignment with business prioritization
- Track of status and progress of regulatory documentation and deliverables required to support regulatory submissions
- Manage product lifecycle activities including regulatory impact assessments of product changes and product labeling development
- Maintain regulatory files in a format consistent with regulatory requirements and internal procedures
- Support local country RA on product Geographic expansion initiatives and product lifecycle activities
- Provide guidance and regulatory strategies to project teams supporting new product development
- Respond to regulatory authority inquires under strict deadlines
- Assist with maintenance activities for regulatory systems and procedures
- May act as primary contact with US FDA and/or EU agencies for standard activities related to product development or compliance
- Required Bachelor’s degree or country equivalent in a scientific discipline with a minimum of 5 years regulatory or equivalent experience within a healthcare company, contract manufacturer, or similar organization. Ideal candidate will also possess working knowledge of medical device registration regulations in the United States. EU and international experience / knowledge in medical device regulations will be an advantage
- Scientific knowledge and ability to discuss technical matters with cross-functional teams.
- Good written and verbal communication and presentation skills
- Good technical system skills (e.g. word processing, spreadsheets, databases, online research, Document Management System)
- Manage multiple projects, activities, priorities and deadlines
- Ability to identify compliance and / or project risks and escalate when necessary
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.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
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Job posted: 2020-09-21