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Brittney Bender

@brittneybender

Message

I lead FDA 510(k) strategy and global medical device regulatory submissions.

United States

Message

At BD, I lead FDA 510(k) strategy and submissions, authoring content, coordinating cross-functional teams, and guiding products through FDA review.

I lead FDA interactions and Additional Information responses while assessing sustaining engineering changes to maintain global market access. I also develop EU MDR technical documentation across Class I, IIa, IIb, and Procedure Pack devices.

Previously at Origen Biomedical, I supported clinical evaluations, post-market surveillance, international registrations, EU MDR transition gap assessments, recalls, and FDA 806 reporting across global markets.

My earlier work at Medtronic supported international regulatory submissions, while my CDC research experience included HPLC, mass spectrometry, method validation, laboratory systems implementation, and technical reporting.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Affairs Specialist II

Current

Jan 2022 - Present (4 years 8 months)

Lead FDA 510(k) regulatory strategy and submission activities, including authoring submission content and coordinating cross-functional inputs. Serve as regulatory lead for cross-functional submission teams and lead FDA interactions and responses to Additional Information requests.

510(K)Regulatory Strategy EU MDR Cross functional Leadership Sustaining Engineering Regulatory Interactions Label Review MDSAP Post Market Surveillance Agile MasterControl Salesforce Veeva

Clinical/Regulatory Specialist

Origen Biomedical, Inc.

Jan 2020 - Dec 2022 (2 years 11 months)

Supported preparation of clinical evaluation reports and post-market surveillance documentation to maintain EU MDR compliance. Assisted in drafting regulatory submissions and coordinated responses to deficiency letters to achieve timely approvals.

EU MDR Clinical Evaluation Reports Post Market Surveillance Regulatory Submissions International Registrations FDA 806 Reporting Vigilance Reporting Label Review

Associate Regulatory Affairs Specialist

Medtronic – Spine Orthopedic Therapy Group

Jan 2019 - Dec 2020 (1 year 11 months)

Supported global regulatory strategies by assisting with international submissions and renewals across Latin America, Brazil, China, and Europe. Prepared and organized submission packages and reviewed documentation for compliance with FDA and international requirements.

Regulatory Submissions International Registrations FDA Compliance Product Lifecycle Management Documentation Review

Research Chemist

Centers for Disease Control and Prevention (CDC)

Jan 2014 - Dec 2017 (3 years 11 months)

Developed and validated analytical methods for trans fatty acid testing using HPLC and mass spectrometry in support of public health initiatives. Trained new staff and supported instrumentation troubleshooting and preventive maintenance of GCMS systems.