Regulatory Affairs Manager - Electromechanical Devices
Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter’s employees are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.
Qualified candidate will support Infusion Therapy, specifically Infusion Pumps and interoperable Baxter or third party products. Regulatory knowledge of Health IT Solutions to deliver innovative value and service to customers and patients. Understand relationships of the infusion system including IV sets and solutions with regard to infusion pumps. Understands hardware and software regulatory requirements and can apply appropriate principles based on product risk/classification.
1) Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
2) Represent or lead the RA function on assigned cross-functional project teams 3) Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
4) Establish appropriate communication within RA and other functions primarily at project level
5) Perform gap analysis and propose solutions
6) Develop and document sound regulatory decisions and justifications
7) Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
8) May review SOP's for compliance with local and global regulations.
Qualifications1) Sound basis of Regulatory knowledge
2) Scientific Knowledge
3) Ability to manage complex projects and timelines in a matrix team environment
4) Software and/or mechanical device knowledge
5) Strong oral and written communication and presentation skills
6) Demonstrated interpersonal skills including strong negotiation skills
7) Ability to independently identify compliance risks and escalate when necessary
8) Ability to lead and coach others
9) Bachelor's degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field, including managing people or projects.
10) Engineering degree or higher degree/PhD will be an advantage.
*Develop and execute Regulatory Strategies,
*Influences change (internal and external),
*Participate on Industry working groups,
*Identify and make risk trade-off decisions,
*Negotiation skills to ensure regulatory requirements are met, deliveries on complex projects and commitments,
*Experience with hardware and software devices
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 email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.