Sam Mirza Email & Phone Number

Hollywood, Fl, Us

Charlotte, North Carolina, Us

Amsterdam, Noord-Holland, Nl

Provide 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.

Amsterdam, Noord-Holland, Nl

Miami Lakes, Fl, Us

Prepared 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

... 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.

Responsible 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.

New Brunswick, Nj, Us

B.S, Civil Engineering

Pre-Medicine