Michael Blasco

Michael Blasco Email and Phone Number

Sr. Director, Regulatory Affairs at Stryker @ Stryker
Michael Blasco's Location
United States, United States
Michael Blasco's Contact Details

Michael Blasco work email

Michael Blasco personal email

About Michael Blasco

Michael Blasco is a Sr. Director, Regulatory Affairs at Stryker at Stryker. He possess expertise in fda, regulatory affairs, quality system, regulatory submissions, medical devices and 8 more skills. Colleagues describe him as "I've had the pleasure of working with Mike for over the past two years. Mike assisted in training me when I began with Abbott Vascular and did a great job in ensuring that I had a good foundation to begin my career. He is constantly strategizing and examining our approaches to solutions to ensure that our approach is the best for the business. He has been a great mentor over the last two years and I look forward to working with him in the future." and "Michael and I worked together at Abbott. Michael was a team member on a team that I led. His input to the team was a driving force for the team. His ideas were right on with the scope of the project. Thanks to him the team accomplished a great deal. I also had the opportunity to review Regulatory Affairs assessments that Michael documented for proposed changes. He is very thorough in his assessments; he takes the time to understand the change, ask relevant questions, and provide the assessment in a timely manner. He is a great asset to any organization."

Michael Blasco's Current Company Details
Stryker

Stryker

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Sr. Director, Regulatory Affairs at Stryker
Michael Blasco Work Experience Details
  • Stryker
    Sr. Director, Regulatory Affairs
    Stryker Aug 2023 - Present
    Kalamazoo, Mi, Us
  • Stryker
    Director, Regulatory Affairs
    Stryker Apr 2019 - Aug 2023
    Kalamazoo, Mi, Us
    Regulatory leader for Stryker Sports Medicine and Communications Business Units. Overseeing a broad portfolio of products including implants (permanent and bioabsorbable), arthroscopy surgical hardware, instruments, software (with AI/ML algorithms) and advanced operating room technologies. Successful track record of helping the business navigate the ever-changing global regulatory landscape. Experience with organic product development as well as acquisitions and integrations.
  • Medtronic
    Director, Regulatory Affairs
    Medtronic Aug 2016 - Apr 2019
    Minneapolis, Mn, Us
    Leader of the Enabling Technologies, CSF Management and Critical Care Regulatory Affairs organization, striving daily to achieve our vision of being a world-class Regulatory Affairs team, seen as results-driven strategic business partner that expedites time-to-market and facilitates global regulatory compliance. Together, we have achieved global success through the launch of the O-arm, Stealth Station and integrations with DBS and Spine implants. I served as a member of the business unit leadership team, and the Medtronic Corporate Regulatory Council in support of pan-Medtronic initiatives.
  • Medtronic
    Senior Regulatory Affairs Manager
    Medtronic Nov 2014 - Aug 2016
    Minneapolis, Mn, Us
    Leader of the Medtronic Neurosurgery Regulatory Affairs organization, covering multiple locations and a diverse product portfolio including Intraoperative Imaging, Laser Ablation, Surgical Navigation, Nerve Monitoring, Powered Instruments, Robotics, and Service in support of therapy solutions for Critical Care, Epilepsy, Hydrocephalus, Neuro Oncology, and Traumatic Brain Injury. Provides regulatory support of cross-business strategy and development, mergers and acquisitions, global regulatory approvals, post-market compliance and building effective relationships with regulators.
  • Medtronic
    Regulatory Affairs Manager
    Medtronic Feb 2013 - Nov 2014
    Minneapolis, Mn, Us
    Site Regulatory Affairs leader, with up to nine direct reports. Effectively built and led a diverse team of regulatory professionals, responsible for global regulatory strategy development, domestic and international regulatory submissions, ongoing change assessment, review of promotional materials, and post-market regulatory compliance. Member of the Colorado Leadership Team, Project Review Committee, CAPA Board, Change/Improve Board, and External Research Review Board.
  • Medtronic
    Principal Regulatory Affairs Specialist
    Medtronic Feb 2011 - Jan 2013
    Minneapolis, Mn, Us
    Regulatory lead for new product development, responsible for global regulatory planning and management of regulatory submissions. Responsible for the review and approval of marketing materials. Spearheaded a major change initiative, obtained executive management approval, conducted a series of company-wide presentations, and lead a cross-functional team responsible for planning and implementing the change. Represented Regulatory Affairs on a number of high profile compliance issues, including the successful management of three global field corrective actions.
  • Gen Probe
    Regulatory Affairs Manager
    Gen Probe Apr 2010 - Jan 2011
    Ca, 92121, Us
    Regulatory project manager of company’s first original PMA in eight years, responsible for tracking deliverables, authoring sections, and managing the regulatory team. Regulatory representative on product development core team for novel technology. Provided regulatory assessment of new products and changes to existing products. Created regulatory strategies for domestic and international markets. Regulatory representative on the Material Review Board, Stability and Specification Committee and Product Quality Committee.
  • Abbott
    Senior Regulatory Affairs Associate
    Abbott Jan 2008 - Mar 2010
    Abbott Park, Illinois, Us
    Managed a cross functional project team for the submission of a pre-IDE for a drug-device combination product program including a highly successful meeting at FDASuccessfully took ownership of an IDE submission and effectively led the team to a submission ahead of the company milestone date Authored and submitted significant sections of an original combination drug-device PMA, including CMC sections in CTD formatProvide ongoing regulatory assessment of new products and changes to existing productsActive regulatory lead on product development teams responsible for the preparation and submission of required IDE supplements, PMA supplements and annual reportsProvide ongoing training and mentoring for other regulatory associates as well as regulatory training presentations to other departments
  • Abbott
    Regulatory Affairs Associate
    Abbott Sep 2005 - Dec 2007
    Abbott Park, Illinois, Us
    Served as primary regulatory contact for the entire portfolio of coronary guide wires, guiding catheters, accessories, and stent implant productsRegulatory lead for several sections of the company's first drug-device combination product PMA submissionProvided strategy and support for the preparation of 510(k) submissionsMaintained CE technical files, 510(k) documentation, and submitted PMA annual reports
  • Stat-Chem, Inc
    Quality/Regulatory Manager
    Stat-Chem, Inc Jan 2003 - Sep 2005
    Appointed Management Representative responsible for all aspects of ensuring quality system compliance including design controls, document control, internal and external audits, and management reviewsContributed to the design and development of the company's first product and the preparation of a 510(k) submission to FDAMaintained FDA device listing and establishment registration. Prepared for and participated in California FDB license inspection processSpearheaded overhaul of quality management system to improve effectiveness and meet the requirements of ISO13485:2003 and 21 CFR 820
  • Stat-Chem, Inc
    Principal Research Associate
    Stat-Chem, Inc Sep 2000 - Dec 2002
    Researched and developed novel point-of-care diagnostics technologiesAuthored quality system procedures and manufacturing process instructions Maintained key vendor relationships to ensure the timely execution of project milestones including design transfer activitiesGained a wide range of technical experience including injection molding, extrusion, ultrasonic welding, process validation, and product manufacturing

Michael Blasco Skills

Fda Regulatory Affairs Quality System Regulatory Submissions Medical Devices Iso 13485 Quality Assurance Gmp Design Control Clinical Trials Pma Corrective And Preventive Action Cross Functional Team Leadership

Michael Blasco Education Details

  • University Of Southern California (Usc)
    University Of Southern California (Usc)
    Regulatory Science
  • University Of California - Los Angeles (Ucla)
    University Of California - Los Angeles (Ucla)
    Physiological Science

Frequently Asked Questions about Michael Blasco

What company does Michael Blasco work for?

Michael Blasco works for Stryker

What is Michael Blasco's role at the current company?

Michael Blasco's current role is Sr. Director, Regulatory Affairs at Stryker.

What is Michael Blasco's email address?

Michael Blasco's email address is mi****@****ail.com

What schools did Michael Blasco attend?

Michael Blasco attended University Of Southern California (Usc), University Of California - Los Angeles (Ucla).

What skills is Michael Blasco known for?

Michael Blasco has skills like Fda, Regulatory Affairs, Quality System, Regulatory Submissions, Medical Devices, Iso 13485, Quality Assurance, Gmp, Design Control, Clinical Trials, Pma, Corrective And Preventive Action.

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