Jennifer Bleasdale

Asheville, NC

386-***-****

ad1hnf@r.postjobfree.com

Professional Summary

Technical Writer and Regulatory Professional with extensive life sciences, information technology (IT), health care, medical device manufacturing, and risk management/insurance industry experience. English degree. Background includes interfacing with Engineering, Regulatory, Quality, Software, and other Subject Matter Experts. Research, develop, write, edit, and proofread documentation intended for professional and non-professional audiences. Superlative grammar, spelling, English usage, and information organization skills. Microsoft Word, Excel, PowerPoint, and SharePoint/OneDrive power user. Madcap Flare, Jira, Jama, Agile, Confluence, Celoxis, Adobe Pro.

Policies, procedures, SOPs, templates, labeling, instructions for use, user manuals, executive briefings, broker briefings, release notes, presentations, training, protocols, scope, methodology, validation, documenting APIs (application programming interfaces). 510(k), PMA, de novo (including breakthrough status) and IDE submissions (FDA), Technical Documentation (CE Mark, EU MDR), Health Canada, and PMDA (Japan), Quality Manuals. Usability, human factors, user experience (UX), cybersecurity, SaaS, cloud, national and international standards.

Professional Experience

Technical Writer and Regulatory Consultant

2011-2023

Draft/review policies, procedures, Service Level Agreements (SLA), Business Impact BIA), runbooks, playbooks, Disaster Recovery Plans, RACI charts, protocols, briefings, methodology, validation, and scope reports, instructions for use, user manuals, quick-start guides, labeling, presentations. PMA, 510(k), and de novo submissions. Update tech files to EU MDR. Update technical documentation and labeling, including IFUs, to EU MDR. Clinical Evaluation Reports according to MEDDEV 2.7.1 Rev. 4. FDA Q-sub preparation and response. Quality documentation and training. Prepare presentations, informational notes, and training and present to/interface with notified bodies and government representatives. Advise on regulatory and quality strategy. Work with development teams including design engineers, human factors, clinical, quality, labeling, biocompatibility.

Recent clients include:

American Academy of Orthopaedic Surgeons (AAOS) (Technical Writer - Registries and Data Science - Present

NTG/TI Holdings, LLC – Transportation Logistics – 11/2022 – 5/2023 (Technical Writer and Disaster Recovery Administrator)

RMS, a Moody’s Analytics Company – catastrophe (hurricane, earthquake, flood, severe convective storm, cyber) modeling – 4/4021 – 10/10/2022 (Technical Writer and Regulatory Lead)

Intuitive Surgical – minimally invasive laparoscopic and endoscopic surgery devices and vision systems, robotic surgery devices – 9/2020-3/2021 (Regulatory Specialist)

Neutron Therapeutics – Radiation Therapy Device – 4/2020-8/2020 (Labeling Specialist)

Canary Medical – Smart implant for orthopedics – 09/2019 – 2/2021 (Labeling Specialist)

Company Confidential – AI platform and AI imaging console – 04/2019 – 08/2019 (Regulatory Strategist)

Catheter Precision – Non-invasive arrhythmia localization – 07/2019 – 09-2019 (Regulatory Strategist – Submissions)

Intersect ENT – drug/device combination products for chronic rhinosinusitis – 01/2019 – 8/2020 (Regulatory Specialist)

TransEnterix – minimally invasive laparoscopic and endoscopic surgery devices and vision systems, robotic surgery devices – 12/2015 – 02/2019 (Independent Regulatory Consultant)

Terumo Heart – intravascular ultrasound and optical coherence tomography – 8/2017 – 6/2018 (Labeling Specialist)

Company Confidential – blood diagnostics device – 9/2016 – 12/2016 (Regulatory Submissions Specialist)

Suture Ease – suture devices for laparoscopic surgery – 7/2015 – 12/2015 (Regulatory Specialist)

Mivi – Neurovascular access devices – 2/2015 – 6/2015 (Regulatory Specialist)

MedComp – vascular access, dialysis products – 10/2014 – 1/2015 (Regulatory Specialist)

Special Pathogens Laboratory – water safety – 6/2014 – 3/2015 (Technical Writer)

Boston Scientific – cardiovascular access products, angioplasty and atherectomy products, stents, monitoring and diagnostics – 1/2013 – 5/2014 (Regulatory – Clinical Evaluation Reports)

ConMed/Linvatec - powered and non-powered instruments and accessories for the orthopedic market – 6/2011 – 12/2012 (Regulatory – Clinical Evaluation Reports)

Additional Consulting Experience

2004-2011

Cordis, a Johnson &Johnson Company Consultant Regulatory Affairs/Project Manager

Consulted on process and researched and prepared regulatory documentation for a major international manufacturer of Class II and III medical devices. ISO 13485 environment.

Researched, managed, and compiled Technical File updates for products (implantable stents, vascular access products) which were successful in satisfying audit by a Notified Body to maintain compliance to MDD 93/42/EEC (2007/47/EC) for CE marking.

Worked with Engineering and Quality Assurance Subject Matter Experts to define Risk Management strategy and determine Risk Management content for Technical Files and Design Dossiers.

Consulted with Regulatory Affairs team to define processes for updating documentation in response to internal CAPA initiative. Developed Technical File template which was adopted as the new standard by the Regulatory Affairs Department

Performed literature searches, acquired and reviewed post-market surveillance data from Subject Matter Experts, and edited Clinical Evaluation Reports required for inclusion in Technical Files according to revised MDD (2007/47/EC).

Worked with Engineering and Quality Assurance Subject Matter Experts to define Risk Management strategy and determine Risk Management content for Technical Files and Design Dossiers.

Prepared Design Dossier Supplements to report significant changes in product or process to European Community third party representative (Notified Body).

Researched and wrote responses to questions from Notified Body which supported subsequent approval of process changes.

Consulted with Subject Matter Experts in Engineering, Quality, Biocompatibility, Labeling, and Design groups as well as third party manufacturers to acquire and confirm regulatory information.

Chester River Hospital Center, Chestertown, MD Credentialing Specialist/Medical Staff Office Assistant

Credentialed new physicians applying for privileges at hospital

Became familiar with JHACO and HIPAA regulations

Generated correspondence and informational brochures

Bard Endoscopic Technologies, Billerica, MA Consultant Project Manager/Technical Writer/Editor

Consulted with product design staff to re-engineer processes and revise/edit Divisional Operating Procedure (DOP) documentation relating to medical device product manufacturing (endoscopic instrumentation).

Integrated regulatory issues including cGMP's, QSR's, CE, OSHA requirements, etc.

Developed presentations and obtained buy-in from management board to facilitate and implement process revisions, with the goal of improving Portfolio Management, increasing research and development efforts, and achieving product marketing goals.

Developed new process training materials; presented training on new and revised procedures to engineering and regulatory staff as well as to the management board.

Arrow International, Reading, PA Consultant Regulatory Affairs/Technical Writer

Researched and wrote regulatory compliance documentation for international manufacturer of medical devices. Devices included angiographic, thermodilution, multiple lumen, electrophysiology, and cholangiography catheters.

Prepared product design dossiers and technical files required to receive “CE mark” authorization for Class II and III medical device distribution in the European Union.

Ensured compliance with ISO standards and Medical Device Directive. Worked with engineers and materials specialist to compile product risk analyses and biocompatibility data.

Wrote clinical data summaries for FDA and European Medical Competent Authority documentation submissions. Used Internet research tools including MedLine.

Investigated and responded to requests for clarification from European Notified Body, leading directly to European marketing approval for company products.

Generated Standard Operating Procedure (SOP) documents. Created manufacturing process flowcharts using ABC Flowcharter and Visio. Assisted in design of Documentum database.

Accepted total responsibility for a comprehensive documentation submission for a medical device/pharmaceutical combination.

Reviewed product promotional/marketing brochures for content and style.

Acted as liaison to Medical Device authorities and company personnel in Germany, United Kingdom, and South Africa.

Technical Skills and Training

MS Windows. Microsoft Office Suite (Word, Excel, Outlook, Access, PowerPoint, FrontPage, Project, Publisher). FrameMaker, PageMaker, Visio, Adobe Professional. Jira, Celoxis, Confluence, SharePoint, Teams, Zoom, WebEx, Slack, SalesForce, Infrastructure, Business Continuity, Disaster Recovery, cGMP, 21 CFR 820 (FDA), ISO 9001, ISO 13485, ISO14971, MEDDEV 2.7.1, MDD 93/42/EEC, European Medical Device Regulation (MDR), CMDR, ANSI, ASTM, NIST, ASOP, SOC, CSIRP, Section 508, FedRamp, ITIL, ISTM, SDLC, AMA Style, Chicago Manual of Style, AP Style, MLA Style. Regulatory Affairs, Quality Assurance, Copywriting, Proposals, Presentations, Training Materials, RFP, RFQ. ERP systems, Agile, Adaptive.

Training

Catastrophe modeling, cybersecurity modeling, property and casualty insurance, quality management systems, design controls, design validation, risk management, document control, supplier quality management, supplier audits, good documentation practices (GDP), good manufacturing practices (GMP), CAPA, MDRs.

Education and Honors

Lebanon Valley College, Annville, Pennsylvania: B.A. English

oCum Laude with Departmental Honors: Fulbright nominee, Dean's List

Nine post-graduate credits in English: Washington College

FDA Small Business Regulatory Education for Industry (REdI): Spring Conference, 2017

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