Regulatory Affairs Specialist
Req #: 1900021D_en
Location: St Paul, MN US
Job Category: Regulatory Affairs
Date Posted: 3/11/2019 10:22:06 AM
Every day, millions of patients and caregivers rely on Baxter's leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we've been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter's employees worldwide are now building upon the company's rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
The Regulatory Affairs Specialist reports to the Sr. Director of Regulatory Affairs and is responsible for:
assisting with the maintenance of worldwide product licensure and introduction of new products to market. Preparing U.S. and international submissions, and providing support for market regulatory approvals. Maintaining standards, license renewals, and providing review and approval for product change management.
Essential Duties & Responsibilities:
Provide regulatory support, and leadership to product development teams for regulatory issues and questions to ensure that regulatory requirements are addressed prior to submission for market clearance.
Assess regulatory requirements (with assistance from senior RA personnel as necessary) and develop global regulatory strategies to obtain timely regulatory approvals.
Prepare U.S. and international submissions for new products and for products with significant changes in timely manner.
Understand global regulatory requirements and establish and maintain good working relationships with regulatory agency personnel.
Provide support to market-released products by reviewing Engineering Change Orders, labeling, documentation of changes, and maintaining product files to ensure compliance with regulatory requirements.
Provide support to pre-release and market-released products by reviewing Document Change Orders, labeling, promotional materials, documentation of changes, and maintaining product files to ensure compliance with regulatory requirements.
Maintenance of, standards, foreign license renewals, and other department materials requiring filing/archiving for traceability and/or reference.
BA or BS in a technical discipline with a minimum of three years of regulatory experience or comparable medical device industry experience in regulatory affairs.
Strong writing skills.
Experience with medical devices with specific experience in:
Class I, II, and III medical devices (and/or pharmaceuticals).
510(k) applications and US device regulations.
Global medical device regulations and submissions (EU, Canada, Australia, Asian countries, Latin American countries, and Middle Eastern countries).
Effective interpersonal skills.
Excellent communication and time management skills.
Proficient computer skills.
BA or BS in a technical discipline with a minimum of three years of regulatory experience or comparable medical device industry experience in regulatory affairs
Ability to work at a computer for a least 8 hours per day.
A Career That Matters
Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
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
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 or call 844-249-8581 and let us know the nature of your request along with your information.