Principal Specialist, Regulatory Affairs

3 weeks ago

Deerfield, United States Baxter Full time

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission. Your role at Baxter Responsible for the implementation of sophisticated global regulatory strategies, acquire and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter's products. Serves as a consultant to managers. Manage regulatory activities relating to specific global portfolio of products/projects. What you will be doing: * Initiate and develop sophisticated regulatory project plans * Identify & prioritize key areas of regulatory risk * Supervise applicable regulatory requirements * Build and maintain regulatory files in a format consistent with requirements * Provide regulatory advice to project teams. * Respond to sophisticated questions from regulatory authorities within strict timelines * Compile and submit, in a timely manner, regulatory documents according to regulatory requirements * Maintain and update existing regulatory authorizations * Manage regulatory activities relating to specific portfolio of products/projects * Prepare, review, and approve labeling and SOP's * Lead or represent Regulatory Affairs in project teams * Provide mentorship and coaching for areas of responsibility to lower level team members What will you bring: * Knowledge of regulations * Scientific knowledge * Project management skills * Manage multiple projects and deadlines * Ability to multitask and prioritize * Interpersonal and communication skills * Strong negotiation skills * Technical system skills (e.g. word processing, spreadsheets, databases, online research) * Ability to work optimally in multinational/multicultural environment * Ability to identify compliance risks and escalate when necessary Baxter is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $96,000 to $132,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. #LI-BAXGEN #IND-USOPS #LI-AR1 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. 118235

#J-18808-Ljbffr

  • Staff regulatory affairs specialist

    1 day ago

    Deerfield, United States iRhythm Technologies Full time

    Full job description Boldly innovating to create trusted solutions that detect, predict, and prevent disease. Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care…Join Us Now! At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers....

  • Manager Regulatory Affairs

    5 days ago

    Deerfield, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes. This person is instrumental in the design,...

  • Principal Compliance Specialist

    3 days ago

    Deerfield, United States Discover Full time

    Maintains and enhances department or functional units in support of the overall compliance program components. - Assists with researching regulatory compliance requirements and evaluating the adequacy of business policies, procedures, training and re Compliance Specialist, Compliance, Principal, Compliance Manager, Specialist, Management

  • Senior Regulatory Counsel

    1 day ago

    Deerfield, United States iRhythm Technologies Full time

    About This Role This position is part of the Legal Department and will support the business globally. The position involves handling major projects, transactions or matters under the supervision of Legal Director, Regulatory, Marketing and Employment and has principal responsibility for planning and directing more discrete projects, transactions, or...

  • Senior Counsel, Regulatory

    3 weeks ago

    Deerfield, 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...

  • Principal Compliance Specialist

    1 week ago

    Deerfield, United States Discover Full time

    Maintains and enhances IT control testing process in support of the overall IT control testing program components. - Manages activities of the IT control testing staff (direct/indirect) and is responsible for the overall integrity and quality of the Compliance Specialist, Compliance, Principal, Compliance Manager, Specialist, IT, Healthcare

  • Principal Compliance Specialist

    6 days ago

    Deerfield, United States Discover Full time

    Models, champions, and reinforces a risk culture of compliance and transparency. - Creates and maintains processes and tools to effectively manage changes (e.g., change intake, change tiering) - Partners with multiple stakeholders (e.g., business, Co Compliance Specialist, Compliance, Principal, Compliance Manager, Specialist, Management, Healthcare

  • Principal Market

    6 days ago

    Deerfield, United States Discover Full time

    Reporting to Senior Manager of Market & Liquidity Risk, the Principal Market & Liquidity Risk Specialist is responsible for implementing, maintaining, and enhancing the market and liquidity risk oversight framework. This is an individual contributor Risk, Specialist, Principal, Management, Accounting, Benefits, Finance

  • Specialist, Global Regulatory Affairs

    3 hours ago

    Deerfield, United States Baxter Healthcare Corporation Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter’s products and therapies are found in...

  • Principal Business Risk Control Specialist

    2 days ago

    Deerfield, United States Discover Full time

    Risk and Control Management Provides education and monitors Consumer Banking employees on the requirements of company policies and standards related to risk and control ownership, the development and execution of new products and services, and contro Control Specialist, Risk, Business, Internal Auditor, Principal, Compliance Manager, Accounting

  • Principal Risk and Control Self-Assessment Specialist

    6 days ago

    Deerfield, United States Discover Full time

    Implement and oversee the RCSA program, including the annual attestation, effective challenge, process management, and reporting. Leverage company policy, standards, and procedures to ensure the RCSA program is executed in accordance with the ORM fra Risk, Assessment, Control, Specialist, Principal, Project Management

  • Associate Director, Clinical Nutrition

    1 month ago

    Deerfield, United States BAXTER Full time

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter’s products and therapies are found...

  • Associate Director, Clinical Nutrition

    4 weeks ago

    Deerfield, United States Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Director, Quality Compliance

    3 days ago

    Deerfield, United States BAXTER Full time

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter’s products and therapies are found...

  • Principal Full Stack Software Engineer

    2 weeks ago

    Deerfield, United States MAC Executive Recruiters Full time

    What you'll be doing Model, design, and build secure and reliable backends systems enhancing speed and scale. Develop RESTful API based architecture. Work together with the development team to develop quality, testable applications based on product and regulatory requirements. Collaborate with product owners and designers to understand user needs and...

  • Junior Onboarding and Risk Specialist

    1 month ago

    Deerfield Beach, United States Segpay Full time

    Job DescriptionJob DescriptionSegpay is a reputable global payment platform that specializes in offering tailored solutions such as payment facilitator services, direct merchant accounts, and secure online payment gateway services to a wide range of clients worldwide. With a focus on online credit card processing for e-commerce businesses and subscription...

  • Customer Complaint Specialist

    11 hours ago

    Deerfield Beach, United States MAU Workforce Solutions Full time

    MAU is hiring a Customer Complaint Specialist at our client in Deerfield Beach, FL. As a Customer Complaint Specialist, you will investigate and document product complaints. This involves reviewing manufacturing records and deviations, examining returned samples, coordinating product evaluations, and analyzing complaint histories for trends. You will be...

  • Customer Complaint Specialist

    2 days ago

    Deerfield Beach, United States MAU Workforce Solutions Full time

    MAU is hiring a Customer Complaint Specialist at our client in Deerfield Beach, FL. As a Customer Complaint Specialist, you will investigate and document product complaints. This involves reviewing manufacturing records and deviations, examining returned samples, coordinating product evaluations, and analyzing complaint histories for trends. You will be...

  • Head of U.S. Reimbursement, Policy and Health Economics

    1 month ago

    Deerfield, 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...

  • Director Government Relations

    13 hours ago

    Deerfield Beach, United States The Learning Experience Full time

    Benefits: Childcare Benefit 401(k) 401(k) matching Bonus based on performance Company parties Competitive salary Dental insurance Employee discounts Free food & snacks Health insurance Opportunity for advancement Paid time off Training & development Tuition assistance Vision insurance Wellness resources About the Role: The Learning Experience - World...