Results-focused and well qualified Regulatory Affairs professional professional with 11 years of experience overseeing regulatory compliance activities in domestic NPI, operations and sustaining functional areas. Highly effective at developing regulatory strategies, submissions and various regulatory documentation. Well-versed in CMF&T's Quality Management System (QMS), portfolio, product application and various lifecycle stages within the CMF&T portfolio. Successful at working collaboratively with cross-functional internal departments as well as external suppliers such as Immersive Touch, Pivot International, etc. Adept at managing concurrent objectives to promote efficiency and influence positive outcomes.
Skills
Organized & Detailed Oriented
Team Player
Results Driven
Reliable and Trustworthy
Analytical and Creative Thinker
Strategic with exceptional Communication Skills
ISO 13485 and 14971
Standards and regulations for FDA, MDD, HC
Skilled in Microsoft Word, Excel, PowerPoint, Outlook, and Publisher
Proficient in Windows and Mac OS
Experienced in MS Project, Hive, Slack
Experienced in RAD, Agile, PLM, SAP/ GTS and SharePoint
Proficient ERP System Knowledge
Experience
03/2016 to Current
Regulatory Affairs SpecialistAbbott Laboratories – Green Bay, WI,
Manage IFU review and approval process.
Authored regulatory submissions for various international agencies such as Health Canada, Australia, etc.
Review and approve labeling and project specific promotional material to ensure compliance with the appropriate regulatory clearances.
Strong working knowledge of FDA, HC and MDD requirements.
GUDID and UDI RA support.
Provides regulatory guidance, review and approval for domestic and international product marketing communications.
RA lead for various high business priorities project teams (NPI, compliance and sustaining) to provide regulatory guidance based on advance regulatory expertise to assure V&V activities, product design and processes are in compliance to applicable regulations, standards and meet Microfix’s QMS requirements.
Primary RA reviewer and approver for product design and change documentation.
Lead RA for the following Projects:.
NeuroOne (Phase 1 Launched 2020 Phase 2 Ongoing).
Sternal Next Gen (Ongoing).
Facility change locations (Pivot and Biovision - Sustaining) (Ongoing).
End of Line (Ongoing).
Atlas CE Mark Removal and product rationalization (Ongoing).
Walter Sustaining Activities (Closed out 2021).
EIFU workstream (Ongoing).
Sterile Thoracic Pack (Launched 2020).
Contra Angle Driver and accessories (Launched 2020).
Partnership between ZB and Immersive touch (Launched 2020).
ZB and Rultract (PEMCO) – (Launched 2019).
ZDrive Post Launch activities (Completed 2019).
Authored various “letters to file” for 510ks.
Trained in 510K writing and processes.
Updated SOPs based on regulation requirement changes.
Prepared documentation for Europe and Australia custom cases.
Trained Regulatory contractors and new hires on Technical files, OCD SCN, PPRs, product label review/approvals, and processing IFUs.
Prepared training material and documentation for RA team.
BSI and FDA audit support.
Supported Japan QMS audits.
Authored and maintained multiple technical files/DMRs.
Authored FDA PMA 30 Day submission (EOL/Hass Lathe Submission in process).
Authored ZDrive’s regulatory submission strategy.
Assembled dossiers according to STED format for NPI.
Authored CE Agreements.
06/2013 to 02/2016
Regulatory Affairs SpecialistAbbott Laboratories – Lagrange, IN,
Managed ENT business unit as the international regulatory lead by providing regulatory guidance and risk mitigations to ensure global product requirements are met prior to commercial release.
Prepare and provide documents requested by global distributors for submissions to the regulatory bodies in order to complete product registrations in a timely manner.
Lead international regulatory specialist for business development divestiture.
Actively completing and managing new product registrations for China, India, Japan, Asia Pacific, Australia, Canada, Middle East, Eastern and Western Europe, and Latin America.
Managed global Product Change Notifications (PCN) for all ENT devices.
Initiated and implemented Engineer Change Notifications (ECN) for various ENT product labeling updates.
Developed strategic partnerships with international marketing teams and engineers to advance ENT’s evolving global business strategy.
Successfully completed Corrective and Preventative Actions (CAPA) in response to the non-conformities reported by the China Food and Drug Administration (CFDA) Implemented monthly product status reporting process for senior management team to provide updates on important product launches and license renewals.
Authored “letters to file” for 510ks.
Successfully registered and maintained product licenses for over 5,000 ENT medical devices.
Created, implemented and trained personnel on various regulatory work instructions.
Assisted in FDA Class I recalls.
Assembled dossiers according to the Summary Technical Documentation (STED) format for both new and legacy products.
Managed and trained team members on the FDA electronic Certificate to Foreign Government process (CFGs).
11/2010 to 06/2013
Associate Regulatory Affairs Specialist, International Regulatory InternMedtronic Xomed, Inc – City, STATE,
Developed and continued to maintain Regulatory Strategic Matrix.
Collaborated with Regulatory Affairs Advisor to write and implement field action plan.
Researched, prepared and submitted documentation in a timely manner to support global regulatory product submissions in various Middle Eastern, European and Latin American regions.
Main contact for Italy and Spain to support product registrations and other regulatory activities.
Initiated new filing structure for product licenses to address audit findings.
Assisted with the development, implementation, and maintenance of department procedures and policies.
Participated in on-site training by Medtronic Japan regulatory experts.
Participated in international registration requirements training for various geographies.
Provided administrative support to assist all levels of regulatory personnel.
Work with our Japan colleagues to prepare GMPi certificates.
Job shadowed other functional areas; Customer Loyalty, Marketing and other Regulatory Specialists.
License Reconciliation Project team member.
Assisted in updating EU technical files to address TUV (Notified Body) findings.
Trained new regulatory interns.
Education and Training
Expected in 2015 to to
RAPs Medical Device Certificate: - , GPA:
Expected in 2015 to to
Regulatory Affairs Professional Society: National Notary Association - , GPA: District 84 – North Florida Toastmasters Club
Expected in 2011 to to
Florida Notary Public September 2012 to September 2020
Commission # EE 837608: University of North Florida - Jacksonville, FL GPA:
Expected in 2010 to to
: - , GPA:
Expected in 2010 to to
Bachelor of Business Administration: International Business, Business Spanish Coggin College of Business, AACSB Accredited - , GPA: GPA: 3.33
Expected in 2010 to to
: - , GPA: received 3 academic credit hours)
Expected in 2010 to to
: - , GPA:
UNF S.T.A.R. (Skills to Achieve Results),,
The National Society of Leadership and Success, Phi Theta Kappa: International Honor Society of two year college, 2009
Who’s Who Among American College and University Students, 2009
Florida State College at Jacksonville Dean’s List
Expected in 2009 to to
: University of North Florida Dean’s List - , GPA:
Additional Information
GUDID
Activities, Achievements and Honors
, Zimmer Biomet Impact Awards:
K.Kachnycz (Focus Award; Sterile Pack Delivery 2020)
C. Thompson (Commit Award; Rultract completion with limited resources 2019
N. Schrauder (Focus Award; Critical change for patient 2019)
B.Drilling (Focus Award; Completion of sustaining project 2019)
S. Bacon (Customer First Award; Kaiser Tender 2018)
B. Hatcher (Focus Award; Walter 2018)
K.Murphy (Customer First Award; Patient 2018)
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Resume Overview
School Attended
National Notary Association
University of North Florida
Coggin College of Business, AACSB Accredited
University of North Florida Dean’s List
Job Titles Held:
Regulatory Affairs Specialist
Regulatory Affairs Specialist
Associate Regulatory Affairs Specialist, International Regulatory Intern
Degrees
RAPs Medical Device Certificate
Regulatory Affairs Professional Society
Florida Notary Public September 2012 to September 2020
Commission # EE 837608