Regulatory Affairs Specialist Resume Example
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REGULATORY AFFAIRS SPECIALIST
Summary
Highly knowledgeable, well-qualified Regulatory Affairs professional with 11 years of experience overseeing regulatory compliance activities in NPI, Operations and Sustaining. Knowledgeable in CMF&T's QMS controls, portfolio, product application and its various stages of product lifecycle. Highly effective at developing regulatory strategies submissions and other regulatory documentation. Successful at working collaboratively with cross-functional internal departments as well as external suppliers.
Skills & Competencies
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Experience
Bd (Becton, Dickinson And Company)April 2016 to CurrentRegulatory Affairs Specialist
North Carolina; Raleigh , NC
North Carolina; Raleigh , NC
Microfix's QMS requirements.
- Evaluate risk of proposed regulatory strategies and offers solutions
- Primary RA reviewer and approver for product design and change documentation and determine regulatory and operational impact.
- Authored various “letters to file” for 510ks.
- Trained in 510K writing and processes.
- Assess design changes for impacts to OUS and US registrations
- 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 ZDrive's regulatory submission strategy.
- Assembled dossiers according to STED format for NPI.
- Authored CE Agreements.
- Gathered and analyzed scientific data to formulate explanations and arguments for regulatory authorities.
Bd (Becton, Dickinson And Company)July 2013 to March 2016Regulatory Affairs Specialist
Omaha , NE
Omaha , NE
- 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).
Medtronic Xomed, IncDecember 2010 to July 2013Associate Regulatory Affairs Specialist, International Regulatory Intern
City , STATE
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.
Projects Led:
NPI:
- NeuroOne (Phase 1 Launched 2020 Phase 2 Ongoing).
- Walter Post Launch Activities (Closed out 2021)
- Sterile Thoracic Pack (Launched 2020)
- Contra Angle Driver and accessories (Launched 2020)
- Partnership between ZB and Immersive touch (Launched 2020)
- Partnership between ZB and Rultract (PEMCO) – (Launched 2019)
Sustaining/ Operations:
- Facility change locations (Pivot and Biovision) (Ongoing)
- End of Line (Ongoing)
- Atlas CE Mark Removal and product rationalization (Ongoing)
- OPM labeling updates for EU MDR & Brexit Compliance (Ongoing)
Education and Training
Regulatory Affairs Professional Society2015Membership
District 84 – North Florida Toastmasters Club
Project Management Institute Membership
Regulatory Affairs Professional Society (RAPS)2015RAPs Medical Device Certificate
Coggin College Of Business, AACSB Accredited2010Bachelor of Business Administration: International Business, Business Spanish
GPA: 3.33
University Of North Florida Dean's List2009
Activities, Achievements and Honors
Zimmer Biomet Impact Awards:
- J. Sharma (Focus to Win - Adapt and Deliver - Honoring commitments 2020)
- J. Williamson (Focus to Win - Adapt and Deliver - Delivering beyond expectation 2020)
- 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; Successful Kaiser Tender 2018)
- B. Hatcher (Focus Award; Walter 2018)
- K.Murphy (Customer First Award; Patient impact 2018)
Member of Medtronic Project 6 - Community service/volunteer program, 2014
Medtronic CERG Committee member, 2014
UNF S.T.A.R. (Skills to Achieve Results), 2010
The National Society of Leadership and Success, 2010
University of North Florida Dean's List, Fall and Spring 2010
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, Fall and Spring, 2009
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Resume Overview
School Attended
- Regulatory Affairs Professional Society
- Project Management Institute Membership
- Regulatory Affairs Professional Society (RAPS)
- Coggin College Of Business, AACSB Accredited
- University Of North Florida Dean's List
Job Titles Held:
- Regulatory Affairs Specialist
- Associate Regulatory Affairs Specialist, International Regulatory Intern
Degrees
- Membership
RAPs Medical Device Certificate
Bachelor of Business Administration : International Business, Business Spanish
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