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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.

This section contains a list of primary responsibilities of this role that account for the majority of the work. The incumbent will perform other duties assigned.

• Serves as a Subject Matter Expert for PostMarket surveillance processes such as complaint handling or Regulatory Reporting.
• Providing complaint processing timeliness oversight and governance.
• Driving global implementation of the PostMarket Surveillance Processes (complaint handling and regulatory reporting) and system.
• Representing PostMarket Surveillance Processes (complaint handling and regulatory reporting) in new product launches, Quality Agreements, and integrations of acquisitions, including leading assigned activities
• Leading and/or participating in implementation of new Standards and Regulations
• Providing oversight and governance (weekly and daily) to the Regulatory Reporting (MDRs, FARs, BPDRs) process to ensure on time submissions. Driving resolution of escalated issues and risks
• Creating and/or analyzing operations metrics (complaint handling process and regulatory reporting) to identify improvement opportunities.
• Writing, reviewing, analyzing, and revising local and global procedures, including facilitation of PS Change Review Board and TCU document management as needed
• Partnering with clinicians or with product owners to understand input needed for reportability determination
• Leading and/or participating 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 and/or lead audit readiness activities.
• May perform other Postmarket activities as assigned

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Ability to perform all duties required of previous levels
• Strong knowledge of the FDA Quality System and Regulatory Reporting regulations (e.g. 21 CFR 803, 806, 820, 211, etc.)
• Strong interpersonal skills
• 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 make independent decisions with minimum oversight and ability to work independently
• Strong problem solving, critical thinking and analytical skills
• Detail oriented
• Ability to effectively communicate across multiple levels within the organization

Include the education and experience that is necessary to perform the job satisfactorily.

• 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

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. 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.