Michael Blasco work email
- Valid
- Valid
Michael Blasco personal email
- Valid
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."
-
Sr. Director, Regulatory AffairsStryker Aug 2023 - PresentKalamazoo, Mi, Us -
Director, Regulatory AffairsStryker Apr 2019 - Aug 2023Kalamazoo, Mi, UsRegulatory 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. -
Director, Regulatory AffairsMedtronic Aug 2016 - Apr 2019Minneapolis, Mn, UsLeader 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. -
Senior Regulatory Affairs ManagerMedtronic Nov 2014 - Aug 2016Minneapolis, Mn, UsLeader 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. -
Regulatory Affairs ManagerMedtronic Feb 2013 - Nov 2014Minneapolis, Mn, UsSite 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. -
Principal Regulatory Affairs SpecialistMedtronic Feb 2011 - Jan 2013Minneapolis, Mn, UsRegulatory 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. -
Regulatory Affairs ManagerGen Probe Apr 2010 - Jan 2011Ca, 92121, UsRegulatory 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. -
Senior Regulatory Affairs AssociateAbbott Jan 2008 - Mar 2010Abbott Park, Illinois, UsManaged 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 -
Regulatory Affairs AssociateAbbott Sep 2005 - Dec 2007Abbott Park, Illinois, UsServed 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 -
Quality/Regulatory ManagerStat-Chem, Inc Jan 2003 - Sep 2005Appointed 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
-
Principal Research AssociateStat-Chem, Inc Sep 2000 - Dec 2002Researched 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
Michael Blasco Education Details
-
University Of Southern California (Usc)Regulatory Science -
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.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial