Sam Mirza Email and Phone Number
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Sam Mirza is a VP International Regulatory Affairs at Dentsply Sirona. He possess expertise in fda, medical devices, regulatory affairs, quality system, regulatory requirements and 15 more skills.
Dentsply Sirona
View- Website:
- dentsplysirona.com
- Employees:
- 10
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Vp International Regulatory AffairsDentsply Sirona Jan 2022 - PresentCharlotte, North Carolina, Us
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Director And Head Of Regulatory Affairs, Image Guided Therapy And Ultrasound Business GroupsPhilips Health Systems Jan 2015 - Jan 2022
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Director, Regulatory AffairsPhilips Healthcare Nov 2013 - Jan 2022Amsterdam, Noord-Holland, NlProvide regulatory support and expertise to all Philips Business units and manufacturing sites worldwide. Regulatory support includes developing regulatory and submission strategies for 510(k)s, IDEs, PMAs, Summary Technical Documents, etc.). Additionally, support Marketing Communication at imaging systems level. Also, responsible for ensuring consistency in regulatory policy and processes. -
Director, Regulatory Affairs Biu IxrPhilips Healthcare Dec 2011 - Oct 2013Amsterdam, Noord-Holland, Nl
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Manager, RaCordis Sep 2000 - Dec 2011Miami Lakes, Fl, UsPrepared original PMA submission for SMART and SMART Control Nitinol Stent Systems. Received letter of recommendation from FDA via an e-mail (See Attached).Prepared Fact Books for product registration in various countries around the world.Prepared multiple Technical Files for Class IIb Endovascular products Prepared multiple 510(k) premarket notifications for Class II endovascular products.Prepared multiple regulatory assessments for Class II (US), Class IIb and Class III (EC) Medical Devices/Combination products.Trained Regulatory Associates on various Cordis Franchise Methods.Participated in the Technical File Audit with the European Notified Body, BSI.Reviewed multiple Change Request documents to ensure compliance with the US and OUS regulatory requirements -
Manager RaCordis Corporation Sep 2000 - Nov 2011... In 2008 I contributed 16 million dollars in savings to Cordis by delivering worldwide regulatory approvals, including US, on time for combination products. Assisted Cordis LLC in San German, PR with Australian TGA Quality Systems Audit.Prepared Summary Technical Document (STeD) for an on-site review by British Notified Body, BSI, for an; This 2-Day review by BSI resulted in zero observations and immediate approval.Responsible for the review and approval of Marketing promotional materials and Labeling for combination products.Prepared an engineering white paper to clarify the amount of drug / unit area on different sizes of a drug-eluting stent.
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Regulatory Affairs ManagerCordis Corporation Jan 2000 - Nov 2011Responsible for the following regulatory activities:Prepared, submitted and received approval from FDA for a 30-Day Notice PMA Supplement for CYPHER Stent with a modified spray coating system with new software.Completed two successful on-site Design Dossier reviews in London with a British Notified Body for the extension of shelf life from 8M to 18M and for the alternate final release test site for CYPHER SELECT + Stent. In Q1 2009 - I negotiated with the European Notified body to convert Design Dossier for manufacturing site transfer to a simple Notification. The company saved approximately $100,000 in fees and labor.Submitted IDE for CYPHER Stent to address FDA requirement of assessing long term benefit of dual antiplatelet therapy for patients.
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Manager, Regulatory AffairsCordis Corporation, Johnson & Johnson 2000 - Nov 2011
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Manager, Regulatory AffairsJohnson & Johnson 2000 - Nov 2011New Brunswick, Nj, Us -
Manager, Regulatory AffairsLasersight Technologies, Inc Jan 1999 - Aug 2000
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Senior Regulatory Affairs SpecialistEbi Medical Systems, Inc Jan 1997 - Jan 1999
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Regulatory Affairs SpecialistSulzer Orthopedics Jan 1995 - Jan 1997
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Regulatory Affairs AssociateOsteonics Corporation Jan 1990 - Jan 1995
Sam Mirza Skills
Sam Mirza Education Details
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Montana State UniversityCivil Engineering -
Ramapo CollegePre-Medicine
Frequently Asked Questions about Sam Mirza
What company does Sam Mirza work for?
Sam Mirza works for Dentsply Sirona
What is Sam Mirza's role at the current company?
Sam Mirza's current role is VP International Regulatory Affairs.
What is Sam Mirza's email address?
Sam Mirza's email address is sa****@****ips.com
What schools did Sam Mirza attend?
Sam Mirza attended Montana State University, Ramapo College.
What skills is Sam Mirza known for?
Sam Mirza has skills like Fda, Medical Devices, Regulatory Affairs, Quality System, Regulatory Requirements, Iso 13485, 21 Cfr Part 11, Design Control, Regulatory Submissions, Capa, Pma, Quality Assurance.
Who are Sam Mirza's colleagues?
Sam Mirza's colleagues are Katleen Van Houdenhove, Robert Lebrun, Cécilia Brault, Marc Settin, Urszula Parecka, Kristina Spurlock-Howard, Lauren Hanna.
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