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Summary: This role is responsible for process related to Postmarket Surveillance Plans, Postmarket Surveillance Reports and Periodic Safety Update Reports (PSUR), and for oversight of activities associated with these documents. This role is also responsible for maintaining schedule, and for ensuring completion of China and Health Canada Annual Product Reports. Ability to handle multiple projects and demonstrate effectiveness in task completion, decision-making, empowerment of others, problem solving and team leadership. A functional understanding of FDA, ISO and Baxter Quality systems is also required.
Essential Duties & Responsibilities:
- Serves as a Subject Matter Expert for processes related to EU required Postmarket Surveillance Plans, Postmarket Surveillance Reports, Periodic Safety Update Reports (PSUR), and China and Health Canada Annual Product Reports.
- Maintaining processes and procedures, including procedural updates and alignment with regional and global regulatory requirement
- Establishing and managing schedule (the Repository Master List) to ensure timely completion of activities and the Postmarket Surveillance documents (PMSP, PMSR, PSUR, China and Health Canada Annual Product Reports), including oversight, tracking, monitoring, and coordination with stakeholders
- Leading ongoing daily departmental activities for areas of direct responsibility and assist other Quality areas in the successful performance of these activities
- Supporting management reviews with providing data and performance related to Postmarket Surveillance documents
- May interface with regulatory agents or internal auditors
- May perform other activities within Quality as assigned
Qualifications
- Ability to effectively communicate (verbal and written) across different functions and across multiple levels within the organization
- Good project management skills
- Strong understanding of international medical device regulations
- Strong critical thinking and problem solving skills
- Ability to work independently and to prioritize effectively
- Ability to drive decisions and actions quickly and effectively
- Ability to make independent decisions
- Collaboration and Teamwork
- Detail Oriented
- Strong technical writing skills
Education and/or Experience
- Bachelor’s degree (Science or Engineering preferred)
- 5-8 years of experience in Quality/Regulatory Affairs, or related field preferred in the medical products industry
- Experience with driving process improvement initiatives and projects
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 minimum salary for this position is €36,800.00 annually. Your initial pay could be at the minimum or higher based on location, skills and expertise, experience, and other relevant factors, all of which are subject to change. This position may also be eligible for competitive benefits, discretionary bonuses, and/or long-term incentive. 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.
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.
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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