Manager, Regulatory Affairs (Remote) job vacancy in Baxter – Jobs in Washington

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Job Details
Company Name : Baxter
Company Location : Bellevue, WA 98008
Job Position : Manager, Regulatory Affairs (Remote)
Job Category : Jobs in Washington

Job Description :
Req # JR – 073059

Location Bellevue, Washington, United States

(remote)

Additional locations United States of America – Remote
Job Category Administrative
Date posted 09/26/2022

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.
Bardy Diagnostics (BardyDx), a division of Baxter International, is an innovator in digital health and remote patient monitoring, with a focus on providing the most diagnostically accurate and patient-friendly cardiac patch monitor in the industry. Currently, BardyDx has FDA 510(k) clearance and CE Mark approval for the Carnation Ambulatory Monitor (CAM) Patch, which is presently launched in the US, the UK, and Canada.
The CAM Patch™is a non-invasive ambulatory cardiac monitor and arrhythmia detection device that is designed to improve patient compliance with its lifestyle-enabling patch design. Designed to be worn comfortably and discreetly by men, women, and children (indicated for patients > 22 pounds), the CAM Patch is placed on the center of the chest, directly over the heart for optimal ECG signal collection. Distinguished from other products by its state-of-the-art sensing technology, the CAM Patch provides optimal detection and clear recording of the P-wave, the part of the ECG waveform that is essential for accurate arrhythmia diagnosis.
Duties and Responsibilities:

Develop/advise company on regulatory strategies for new medical device products and modifications to existing products in alignment with applicable regulations and business needs.
Support product development and sustaining engineering projects – RAQA project guidance for hardware and software projects, document review & feedback, provide appropriate design control requirements for differing development phases.
Prepare regulatory documentation and manage pre-market submissions to relevant authorities (e.g., letters to file, significant change assessments, pre-submissions, 510(k)s, Canada medical device license applications).
Technical File/Documentation creation, maintenance, and audit support.
Effectively interface with internal stakeholders and external regulatory authorities and other technical resources (e.g., FDA, Notified Body, Health Canada, external consultants).
Monitor applicable regulatory requirements; assure compliance with internal and external standards.
Develop/advise company on pre-market clinical studies, participating in execution of studies, and preparing required regulatory submission documentation.
Conduct risk management activities: hazard analysis, risk analysis, identify and evaluate risk control measures for supported projects.
Follow documented procedures for all activities related to the Company’s Quality System.
Support other areas of the Quality System and perform other tasks as defined by Management.

Qualifications:

Bachelor’s degree or equivalent in technical discipline, such as engineering, biology, chemistry, healthcare. Master’s degree or equivalent and/or Regulatory Affairs Certification (e.g., RAC) preferred.
Minimum of seven (7) plus years of progressive experience in medical device regulatory affairs. Quality assurance and quality engineering experience desirable.
Successful preparation and submission of 510(k)s and/or international documents and registrations.
Strong working knowledge of US and international medical device regulations and standards, including 21 CFR (e.g., 820, 803, 806, 807), MDD/MDR, ISO 13485, CMDR, MDSAP, ISO 14971, IEC 60601, IEC 62304, IEC 62366.
Experience with developmental best practices for medical device hardware and software, including electromechanical medical devices and both embedded and non-embedded software. Experience with artificial intelligence and SaMD preferred.
Strong oral and written communication and presentation skills. Demonstrated interpersonal skills including strong negotiation skills.

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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.

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. 073059
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