Manage medical device aspects of drug-led combination products for both development and lifecycle programs. Develop regulatory strategies, create submissions, assess changes, and interact with Health Authorities in both the US and the EU.• Create eCTD submission content, CE technical files (MDD and MDR), and Article 117 Notified Body Opinion (NBOp) documents for sterile injectable and nasal spray combination products as well as co-packaged class I and Is medical devices.• Support drug-device combination product lifecycle changes.• Provide regulatory leadership for DHF remediation activities for multiple products and teams.• Submitted an MDR technical file for a class Is device in October 2023 with assessment ongoing.

GCMC product lead for 10 pharmaceutical products (Pfizer) marketed in over 60 countries (US, CA, EU, AfME, Latam, AsiaPac). Two of these products were drug/device combination products.• Authored post-approval CMC variations including query responses to health authorities.• Developed regulatory strategy and managed medical inquiries.

Regulatory Product Lead supporting registrations of blood component equipment and disposables worldwide. Core team representative on cross-functional new product teams.

Served as the regulatory lead on a large cross-functional team supporting manufacturing process remediation.• Authored U.S. regulatory submissions for class 2 and class 3 laser ablation devices (510(k)s, 30-Day Notices, Special PMA Supplements) and EU dossier supplements.• Managed change control and provided international regulatory support.

Managed U.S. CMC regulatory submissions for 100+ commercial generic pharmaceutical products in the US, including PAS, CBE, Annual Reports, and amendments in eCTD format. Evaluated product changes and devised strategies to uphold submission objectives. Authored, published, and submitted 250+ submissions annually.

• Responsible for CE technical files and other international submissions• Regulatory member of team transferring 500+ products from an acquired company to Colorado

• Responsible for 510(k), LTFs, CE technical files, international submissions• Create innovative regulatory database to track domestic and international regulatory information for over 10,000 products• Domestic medical device registrations

As the Regulatory Lead, I was part of the "Innovative Project Team of the Year in 2013" and successfully secured 510(k) clearance for the LigaSure LF1637 Laparoscopic Sealer/Divider within a period of 17 days.Furthermore, I served as a key member within new product development teams, leading FDA submissions, regulatory evaluations, preparation of CE technical files, technical documents, and other essential paperwork necessary for both domestic and international product registrations.

• Core team member on new product development teams; responsible for FDA submissions, regulatory analyses, CE technical file, technical document, and other documents required for domestic and foreign product registration• Regulatory representative on the hazardous substance project team, ensuring proper environmental regulatory guidance to regulations such as RoHS, REACh, China RoHS, WEEE, MDD, and others• Develop an innovative regulatory sharepoint site and database• Develop quarterly Regulatory Intelligence

Independent consultant in pharmaceutical and medical device industries, specializing in technical writing in regulatory and quality. Some examples include:• Created content for CMC section of NDA (eCTD) for a pharmaceutical product which was approved by the FDA in June 2007• Created technical content for other regulatory submissions such as pre-NDA, IND, IMPD, and annual reports • Performed quality assurance reviews of submissions to ensure accuracy• Collected reference data for regulatory submissions, and organized and managed this data in preparation for FDA audit• Researched guidance documents written by ICH, EMEA, and FDA for submissions requirements, and created a report which served as a guide in writing the NDA• Created original content for SOPs in a small start-up medical device company, enabling them to comply to regulatory and quality standards quickly• Created manufacturing procedures (batch records), work instructions, and other documents which allowed manufacturing and production groups to successfully release products on schedule• Developed the complaint, nonconforming material, CAPA, and document change control databases and procedures within three months of working at a small start-up company. Systems were approved and used by the company immediately• Organized and managed controlled files and documents subject to regulatory audit (ISO and FDA/QSR), which enabled auditors, management, and others to find files quickly and easily• Coordinated and conducted internal audits of facility and QC systems such as material inspections, calibrations, preventative maintenance, and batch records• Tracked and trended environmental monitoring, stability, temperature monitoring records, and other types of data to ensure data was within limits of compliance• Facilitated collaborative meetings between Manufacturing, Process Development, Quality, and Technical Writing departments, which produced complete and accurate documentation.

• Managed client timelines, lab schedules, and technical and QA report reviews• Successfully managed a team of technical writers to ensure accuracy and timeliness of reports• Reviewed raw and intermediate data which ensured accuracy, validity, and compliance with client expectations and proposal

• Trained QC Chemists to perform new analytical methods and coordinated method improvements• Developed and optimized analytical methods for ribozymes using various analytical techniques• Conducted method development, validation, and transfers under GLP and cGMP guidelines• Assisted other chemists in general analytical lab techniques, including instrumentation and assay troubleshooting

• Developed and optimized analytical methods for DNA oligonucleotides, phosphoramidites, and nucleotide triphosphates using various analytical techniques• Conducted method development, validation, and transfers under GLP and cGMP guidelines• Conducted raw material and final product QC according to cGMP regulations, ensuring product quality in a start-up pharmaceutical company