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Rachel Parker

@rachelparker1

Experienced Scientific Writer with expertise in regulatory compliance.

United States
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What I'm looking for

I am looking for a role that values collaboration, innovation, and professional growth in regulatory writing.

I am an experienced Scientific Writer and editor with a strong background in technical communication, regulatory compliance, and technical documentation. I have a proven track record of interpreting complex scientific data and translating it into clear, concise, and engaging content for diverse audiences. My ability to collaborate with subject matter experts (SMEs) and manage project timelines has consistently resulted in high-quality standards in medical and technical documentation.

In my current role as Principal Content Developer at Terumo BCT, I lead the development of instructional labeling and technical documentation for hardware, disposables, and software projects. I ensure compliance with regulatory standards while collaborating closely with cross-functional teams to create user manuals, IFUs, and training materials for medical devices. My initiatives to streamline regulatory documentation processes have significantly improved compliance and expedited submission turnaround times.

With a Master’s degree in Analytical Chemistry and extensive training in medical writing and regulatory documentation, I am dedicated to maintaining accuracy and clarity in all written materials. I am passionate about mentoring junior writers and continuously updating content to reflect changes in regulatory requirements and customer feedback.

Experience

Work history, roles, and key accomplishments

TB
Current

Principal Content Developer

Terumo BCT

Jan 2019 - Present (6 years 9 months)

Led the development of instructional labeling and technical documentation for hardware, disposables, and software projects, ensuring compliance with regulatory standards and timely localization for international markets. Collaborated closely with cross-functional teams, including R&D, design, and regulatory departments, to create user manuals, IFUs, and training materials for medical devices. Mana

ME

Technical Writer

Medtronic

Jan 2018 - Present (7 years 9 months)

Authored and updated technical documents (IFUs, user manuals, and training materials) for medical devices in compliance with EU MDR and internal regulations. Coordinated and led weekly project meetings to review documents, timelines, and milestones with cross-functional teams. Conducted gap assessments, human factors assessments, and cost evaluations to identify opportunities for process improveme

Education

Degrees, certifications, and relevant coursework

University of Colorado Denver logoUD

University of Colorado Denver

Bachelor of Science, Analytical Chemistry

Obtained a Bachelor of Science in Analytical Chemistry, building a strong foundation in chemical analysis and laboratory practices.

University of Colorado Denver logoUD

University of Colorado Denver

Master of Science, Analytical Chemistry

Completed a Master of Science in Analytical Chemistry. The program focused on advanced analytical techniques and research methodologies.

Tech stack

Software and tools used professionally

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Rachel Parker - Principal Content Developer - Terumo BCT | Himalayas