Livecareer-Resume
Jessica Claire
, , 100 Montgomery St. 10th Floor
Home: (555) 432-1000 - Cell: - resumesample@example.com - -
Expertise
  • Over 10 years’ experience in the medical device industry specifically leadership and hands-on positions in the regulatory, quality control, quality assurance, and quality system, disciplines. Primary professional focus is on global regulatory requirements and quality for medical devices and combination products.
  • Experience working in quality systems where regulations and guidelines are followed, including 21 CFR Part 820, 21 CFR Part 11, MDSAP, EU MDR, EU MDD, ISO 13485.
  • EU MDR Remediation: Clear understanding on the new EU Medical Device Regulation (EU MDR), with methodical remediation process to ensure client products retain CE Mark. Experience with supporting EU MDR Technical documentation remediation for CE Marked products.
  • Responsible for project timelines and management of international regulatory submissions including technical documentation (EU MDR), Substantial Changes and Amendments (EU MDD/ EU MDR), EU submissions resulting from UK exit (Brexit) and other countries with EU MOA etc., to ensure compliance with the international regulations and guidelines.
  • Product registration support across APAC, LATAM, EMEA, South East Asia, Australia, Canada, China, Russia, Middle East.
  • Preparing the Country specific STEDs for Rest of World (ROW) registration/re-registration of Medical devices or license renewal.
  • Entrepreneur: Co-founded and established the Regulatory Services Division of American Preclinical Services in September 2016. Founder and Managing Director of Global Medical Device Regulatory Consultants, PLLC in July 2019.
  • Product Types: Experience in implantable and non-implantable medical devices in the areas of: cardiovascular, Telehealth, Neonatal and Biologics. Biologics experience includes blood component packaging and pathogen reduction in blood components.
  • Specific Products: Peripheral and coronary balloon catheters, pleural catheters, introducer sheaths and dilators, ablation catheters, guide catheters, guidewires, vascular introducers, cardiovascular stents, and cardiovascular drug coated stents., guide wires, TeleHealth, Vascular occluders/plugs.
  • Regulatory Strategies: Developed multiple global regulatory and quality assessments and strategies.
  • Regulatory Intelligence: Research of global regulatory requirements for medical device and combination product.
  • Regulatory Applications: Provided technical leadership, project management and final review of multiple FDA submissions, including: 510(k)’s, pre-IDE’s, IDE’s, IDE Supplements, IDE annual reports, Master Files, PMAs, PMA Supplements and PMA Annual Reports. Developed multiple international product marketing and registration applications.
  • Compliance Activities: Developed regulatory and compliance strategies for numerous new products. Reviewed and approved website, labeling and promotional materials. Facilitated Notified Body audits. Developed and implemented FDA QSR and ISO 13485 compliant quality and regulatory procedures to meet global requirements. Developed Quality Plans and facility transfers.
  • FDA Expedited Access Program (EAP) designation: Lead Regulatory consultant for a novel implantable pediatric device Expedited Access Program (EAP) Designation/Breakthrough Designation request. Also, facilitated the negotiations in obtaining agreement with FDA on the data development plan for the device.
  • Global Rebranding and Brexit Remediation: Leading rebranding of St. Jude Medical products to Abbott Medical in EMEA, LATAM, Asia-Pacific, Canada, China, Japan, Australia, Middle-East and Africa.
  • Clinical Experience: Reviewed clinical strategies, created IDEs, clinical study protocols/reports. Regulatory reviewer and approver of clinical site activations.
  • Industry Advisor: Served as Industry Advisor for two St. Cloud State University Regulatory Affairs and Services (RAS) graduate students, in their industry focused RAS culminating project.
  • Training & Supervision: Managed and mentored medical device, and biotechnology, global regulatory, quality assurance, quality system, quality control testing, quality control inspection, calibration and preventative maintenance, documentation control, audit, and supplier quality control personnel. Developed and conducted multiple quality system and regulatory requirements training.
  • SELECT THERAPEUTIC AREA:
  • Peripheral - Vascular (Ablation, Embolic protection)
  • Hematology – Packaging and Pathogen Reduction
  • Cardiology - Structural Heat (Heart Valves, ASD, PFO, LAA)
  • Cardiology - Interventional (Coronary Stents, Coronary Stents/DES, Guidewires, Guide Catheter)
  • Cardiology - Electrophysiology (Pacemakers)
  • Dental – Sterilization Cassettes and Holders
  • Ophthalmic – Contact Lens Care Products
  • Newborn Care Products & Services - neonatal assessment and treatment, including hearing screening, brain injury, eye imaging, thermoregulation, and jaundice management
  • Telehealth - Integrated Clinical Telehealth Services
  • KEY RELEVANT SKILLS:
  • Regulatory Affairs Submissions -510k, PMA, Technical Documentation
  • Regulatory Affairs - Regulator Meetings and Strategy Assessments
  • Regulatory Affairs - Training/Teaching
  • International Regulatory Affairs – Regulatory submission in EMEA, LATAM, Asia-Pacific, Australia/New Zealand, Middle-East and Africa
  • Rebranding – Global product rebranding in EU, USA, Canada, EMEA, LATAM, Asia-Pacific, China, Japan, South Asia, Australia, Middle-East and Africa
  • Business Development - Proposal Preparation and bidding
  • Validation - Manufacturing
  • Quality Systems -SOP Development
  • Quality Systems – Training/Teaching
Skills
  • Project Management
  • US and Rest of World Medical Device Regulatory
  • EU MDR/EU MDD
  • Regulatory Strategic business planning and Implementation
  • Medical Device Policy and Procedure Development
  • Employee Management
  • Financial leadership
Experience
07/2019 to Current
Founder & Managing Director Clarivate Plc Portland, ME,

Name of Client: HireGenics/TapFin/Abbott Laboratories

Contractor Primary Contact Person: Beatrice Claire

Commencement Date: 13 July 2020

Completion Date: 12 Feb 2021

Directs activities related to business development, growing and sustaining GMDRC offerings involving the regulatory environment for medical devices with an emphasis in regulatory strategy development for clients, based on preclinical, clinical and post-market regulatory requirements. Provides input for regulatory strategies and requirements for medical device products to ensure appropriate regulatory strategy and timely, accurate regulatory submissions for clients.

  • Responsible for implementing and maintaining the effectiveness of quality system.
  • Supported manufacturing/operations day to day activities for change control.
  • Provided consultation/advice to regulatory specialist for change control and product development. Provided regulatory direction/interpretation on team activities.
  • Interpreted and apply regulatory understanding to support products and teams.
  • Prepared U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
  • Handled regulatory activities involved in documentation, labeling, field support.
  • Applied regulatory and technical knowledge to a wide variety of complex work assignments.
  • Maintained and ensured compliance to the appropriate quality systems for the specific medical device(s) designed or manufactured that the individual supports.
  • Ensured compliance to and demonstrated knowledge of site and division level policies and procedures.

Accomplishment

  • Main RA representative in Abbott Electrophysiology and Vascular (catheters and introducers) Rebranding + Brexit Core Team for 18 Class III and Class I products.
  • Soley supported fast-paced rebranding submissions in all ROW countries (64 countries) where regulatory impact was assessed, including all EMEA, Middle East, Africa, LATAM, China, South Asia, Asia-Pacific and Canada.
  • Created and maintained the Regulatory Strategy and Rebranding Implementation Plan to ensure that the approval and launch of the rebranded product met the regulatory requirements of individual countries.
  • Processed legalization/apostil of federal documents by US Secretary of State, Minnesota Secretary of State and the respective country embassies, where needed for:
  • CFG
  • FSC
  • ISO Certificates (Design Examination Certificate, ISO 13485 and Full Quality Assurance Certificates)
  • Letters of Authorization for Distributors and In-Country Representatives
  • Power of Attorney (PoA) for Distributors and In-Country Representatives.
  • Specialty Letters, where required.
08/2016 to 10/2019
Director, Regulatory Consulting American Preclinical Services, APS City, STATE,

Directs all activities related to business development, growing and sustaining company offerings involving the regulatory environment for medical device products with an emphasis in biocompatibility testing. Performs overall preclinical / regulatory strategy development for clients. Facilitates APS business development activities. Provides scientific / technical oversight of biocompatibility related activities. Provides input for regulatory strategies and requirements on medical device products internally and with clients to ensure appropriate regulatory strategy and timely, accurate regulatory submissions.

Accomplishment

  • Partnering with the APS President and executive management in establishing APS Regulatory Consulting Services as a new division of APS.
  • Led a sponsor in successfully obtaining Expedited Access Pathway (EAP) Designation and priority review for a 3D Printed Bioabsorbable Tracheobronchial Splint on February 24, 2017.
  • Established and implemented a streamlined process for responding to US FDA and other regulatory agency request for additional information on submitted preclinical test reports.
  • Consistently facilitated business operations for regulatory and biocompatibility services, including presenting offerings to current and potential clients, assisting in the preparation of quotes for services, and providing ongoing regulatory and technical support.
  • Business development, representing APS Regulatory Services at conferences and exhibits.
  • Managing and guiding large and small business clients through the process of EU MDR Remediation by addressing the requirements that include but not limited to device classification, establishing Economic Operators, completing gap assessments for products CE Marked under MDD, as well as, implementation (i.e., collaborating with cross-functional team to establish the Safety and performance checklist, Technical File, risk management according to ISO 14971, UDI System, Post Market Surveillance (PMS), Post Market Clinical Follow-Up (PMCF), Clinical Evaluation according to MEDDEV 2.7.1 Rev.4., and EUDAMED registration per the EU MDR).
04/2016 to 10/2019
Project Manager, RA Validant/St. Jude Medical, Sylmar City, STATE,

Collaborated with the St. Jude regulatory staff in the preparation of an original PMA (traditional) for expansion of an indication for use for a 510k cleared product. Responsibility included but not limited to the following PMA sections; device manufacturing (quality systems and software), animal studies summary, proposed labeling, referenced performance standard/voluntary standard, environmental assessment under 21 CFR 25.20(n) ((d)(i) or (ii), pediatric use - per 515A(a)(2) of the FD&C Act, statements/certifications/declarations of conformity, issues identified by FDA prior to PMA submission. Participated in cross-functional product development and manufacturing project teams. Provided guidance to project team on content for the PMA submissions for assigned sections. Perform other duties and projects as assigned by Manager, Regulatory Affairs.

Accomplishments

Client: Validant and St. Jude Medical

Project Title: Project Manager, RA

Commencing Date: Sep 2017

Completion Date: Dec 2018

Location: Abbott (SJM) CRM – Sylmar, CA

Assist Client with both US and EU product submissions for CRM product.

  • Assist Client with gathering regulatory impact assessments from Client international regulatory.
  • Assist Client with assessment of changes and maintaining documentation on changes for FDA 30-Day Notices, Annual Reports, as well as TUV changes (substantial and insubstantial)
  • Provide other services as mutually agreed upon by the parties.
  • Contractor Personnel shall provide other services as mutually agreed upon by the parties.
01/2018 to 07/2021
International RA Manager Alku/Natus Medical City, STATE,

Collaborated with Natus Medical in-country affiliates and distributors in the registration of Natus Medical products and maintenance of approvals in Latin America countries, Australia, Eastern Europe, Canada, Malaysia, Taiwan, Japan, China, and Indonesia

Client: Natus Medical

Role: International Regulatory Affairs Manager

Commencing Date: 2 January 2019

Completion Date: 30 June 2019

Project Length: 6 months

Accomplishments:

  • Collaborated with the in-Country Natus Medical RA affiliates and distributors in the creation of manufacturing and product change assessment tools, product registration aid for Latin America countries, Eastern Europe and South East Asia.
  • Processed required documents for new product approvals and license renewals.
  • Reviewed and approved engineering change orders.
  • Completed International pre-notification of engineering change orders for assessment of regulatory impact.
Education and Training
Expected in 2010
Master of Science: Regulatory Affairs and Services
St. Cloud State University, College of Science and Engineering - St. Cloud, MN
GPA:
Expected in 2001
Bachelor of Arts: Biology
Southwest State University - Marshall, MN
GPA:
Cum Laude
Expected in
Completed over 40 hours of Computer courses (Earned a Computer Essentials Certificate):
Normandale Community College - Bloomington, MN
GPA:
Accomplishments
  • PROFESSIONAL DEVELOPMENT:
  • Industry Advisor serving graduate students at St. Cloud University School of Engineering Regulatory Affairs and Services Graduate Program.
  • Guest speaker at RAPID+TCT 2016, 2018.
  • Member of American Society of Mechanical Engineers (ASME) AM Medical Additive Manufacturing & 3D Innovation.

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Resume Overview

School Attended

  • St. Cloud State University, College of Science and Engineering
  • Southwest State University
  • Normandale Community College

Job Titles Held:

  • Founder & Managing Director
  • Director, Regulatory Consulting
  • Project Manager, RA
  • International RA Manager

Degrees

  • Master of Science
  • Bachelor of Arts
  • Completed over 40 hours of Computer courses (Earned a Computer Essentials Certificate)

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