Director, Global Regulatory Affairs - IOLs @ Alcon
Director, Global Regulatory Affairs @ Alcon
Regulatory Affairs Manager @ BD
Northwestern University - Kellogg School of Management
Responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the
Responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business.
- BD MAX molecular diagnostics
- BD Kiestra laboratory automation
- BACTEC blood culture instruments and collection bottles
- BACTEC MGIT instruments, culture tubes and AST reagents
- BACTEC MGIT TBcID
- BD/BBL prepared plated and tubed culture media
- BD Innova automated plate streaker
Specialties: Medical devices, advertising and promotion, in vitro diagnostic devices, pre-market communication, Pre-IDE, Pre-Sub, 510(k), CE marking (MDD, IVDD), de novo, CLIA, OTC drugs and medical devices, FDA, Health Canada, Japan PMDA, China CFDA, EU, import, export, import for export
Regulatory Affairs Manager @ Molecular diagnostics - infectious disease From October 2014 to Present (1 year 3 months) Associate Manager, Regulatory Affairs @ From May 2014 to October 2014 (6 months) Regulatory Affairs Project Manager @ - BD MAX molecular diagnostics
- BD Kiestra laboratory automation
- Co-author: “Medical Devices: US Regulations” RAPS Online University, 2012 revision.
- 2012 - 2014 RAPS Annual Conference Planning Committee Member
--- Track Leader: Medical Devices and IVDs
--- Session Leader: Medical Device and IVD Advertising and Promotion in the US
- Invited speaker: Compliant Promotion of Medical Products Conference
---Outlining allowable product communications prior to launch
- Invited speaker: 4th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference
---Maintaining a Global Mindset During Diagnostic Clinical Trials
---Best Practice Utilizing the E-copy Program for Regulatory Submissions From August 2012 to May 2014 (1 year 10 months) Regulatory Affairs Specialist @ • Understand and interpret U.S. and international medical device and in vitro diagnostic device (IVD) regulatory requirements; provide guidance on requirements to product development teams.
• Operate as a core team member (cross-functional team) from the regulatory affairs department during the new product development cycle. Develop extended teams and coordinate activities with respect to the project goals as defined by the core team.
• Develop strategies for submissions to FDA and other regulatory agencies. Provide risk assessments and regulatory options.
• Prepare U.S. regulatory submissions necessary for new product market clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements; Investigational Device Exemptions (IDE).
• Prepare and/or compile information required by ex-U.S. regulatory associates to register or license products outside the U.S.
• Interact and negotiate with U.S. regulatory agencies.
• Coordinate and prepare additional data/information requested by regulatory agencies and prepare appropriate responses to all such requests.
• Participate in the development and review of product release documents.
• Review clinical protocols to assure collection of appropriate data for regulatory submissions. Periodically monitor status of clinical studies and review analysis of resultant clinical study data. Based on these data and considering the regulatory requirements, recommend appropriate courses of action.
• Review labels, labeling, and promotional materials for compliance with applicable regulations and policies.
• Provide regulatory opinions on premarket regulatory requirements, export, and labeling requirements. From January 2009 to August 2012 (3 years 8 months) Manager, Regulatory Affairs @ - Medical device submissions (Class I and II): 510(k), 510(k) de novo, Pre-IDE, 513(g), Device Registration and Listing, Establishment Registration
- OTC drugs: Drug registration form 2657, Drug establishment registration, HPUS compliance
- Complaince requirements for cosmetics and dietary supplements
- Filed unique 510(k)s including clearance of the first over-the-counter (OTC) immunochemical fecal occult blood test and a submission to obtain the first clearance of an OTC infectious disease test.
- Obtained CLIA-waivers for rapid-use point-of-care devices.
- Experience handling multiple 510(k) submissions simultaneously.
- Clinical trial design.
- Held meetings with FDA CDRH/OIVD staff.
- Health Canada CMDCAS submissions.
- Oversaw import/export and Customs filing requirements.
- Established and maintained cGMP/QSR compliant quality system for multiple locations.
- Coordinated FDA inspections at European manufacturing sites and assisted in responding to FDA post-inspection comments.
- Implemented ISO 13485.
- Established a control system compliant with State of CT regulations for pharmaceutical wholesale and obtained a pharmaceutical wholesale license.
- Set-up a cGMP/QSR compliant manufacturing facility in Mexico for Class I (exempt) medical devices. From June 2001 to December 2008 (7 years 7 months)
Master's Degree, Biotechnology @ The Johns Hopkins University From 2014 to 2016 Bachelor's Degree, BS, Biology @ Loyola University MarylandRAPS Executive Development @ Northwestern University - Kellogg School of Management Paul Swift is skilled in: FDA, Regulatory Affairs, Medical Devices, Regulatory Submissions, Regulatory Requirements, Design Control, Medical Diagnostics, CE marking, CAPA, Validation, PMA, IVD, V&V, Medical Device Directive, ISO 14971, Infectious Diseases, 21 CFR
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