Hope Walker Email & Phone Number

I am a dedicated Regulatory Affairs Specialist with a foundation in Biomedical Engineering and a passion for ensuring compliance and quality in the medical device industry. My expertise spans interpreting and implementing international standards such as ISO 13485, ISO 14971, and FDA QSR/QMSR (21 CFR 820). With a proven track record in regulatory submissions, quality system management, and risk-based thinking, I excel at driving seamless regulatory processes and fostering cross-departmental collaboration.Highlights of my professional journey include completing ISO 13485 Lead Auditor Certification in 2023, working toward RAPS Device Certification, and developing quality metrics to enhance compliance and product excellence. My hands-on experience with technical documentation, internal audits, and interfacing with regulatory bodies equips me to navigate the complex landscape of medical device approvals effectively.I thrive in roles that challenge me to solve problems, optimize processes, and contribute to the delivery of safe, high-quality medical devices to global markets. Open to remote or relocation opportunities, I look forward to connecting with professionals and organizations that share my commitment to innovation and quality.

Listed skills include Matlab Programming, C++, Microsoft Excel, Microsoft Office, and 1 others.

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  Milwaukee School Of Engineering

  Biomedical/Medical Engineering