Associate-II, Product Surveillance

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.

This position is responsible for providing oversight for the global complaint handling process and regulatory reporting, as well as identifying, assessing, and working to correct regulatory and quality risks. This position serves as subject matter expert for PostMarket surveillance processes such as complaint handling or Regulatory Reporting.

What you'll be doing

• Serves as a Subject Matter Expert for PostMarket surveillance processes such as complaint handling or Regulatory Reporting.
• Assisting in managing daily work assignments and workflows for reportability decision trees and Regulatory Reports to ensure on time reporting. May be responsible for distributing daily assignments to assigned team.
• Completing and documenting reviews of reportability decisions for accuracy. Responsible for final reportability determination, and/or:
• Completing (performing peer review and submission) of Regulatory Reports. Responsible for accuracy and congruency of the MDRs, FARs or BPDRs.
• Assessing investigation results for content related to Regulatory Reports and management of escalations to other functions
• Managing a workflow of Regulatory Reports and monitoring timely submissions
• Partnering with clinicians or with product owners to understand input needed for reportability determination
• Analyzing PostMarket surveillance MDRs information to identify escalations or improvement opportunities
• Leading and/or participate in cross functional continuous improvement activities and projects, including NCRs/CAPAs.
• Leading mentoring and training of the PostMarket Surveillance team.
• May interface with regulatory agents or internal auditors.
• May perform other Postmarket activities as assigned

What you'll bring

• Strong knowledge of the FDA Quality System and Regulatory Reporting regulations (21 CFR 803, 806, 820, and 211).
• Ability to perform all duties required of previous levels
• Strong interpersonal skills
• Readily accepting of assignments to new/different products
• Ability to prioritize multiple tasks
• Ability to lead people and encourage teamwork
• Customer focus
• Ability to drive decisions quickly and effectively
• Proficient with computers
• Excellent written/verbal communication and organizational skills
• Ability to effectively communicate across multiple levels within the organization
• Ability to make independent decisions with minimum oversight and ability to work independently
• Strong problem solving, critical thinking and analytical skills
• Detail oriented

Education and/or Experience.

• Bachelor's degree (life sciences preferred) or clinical certification (MT, RN) or equivalent experience (defined as a minimum of 5 years of medical products industry experience)
• 2-5 years relevant work experience in cGMP related industry or in a clinical setting.
• Experience with driving process improvement initiatives and projects preferred Application of lean principles preferred

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 our employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $60,000 to $132,000 and also includes an annual incentive bonus. The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location

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

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