Heather Cronin Email and Phone Number
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Specialties: Clinical Study, Clinical Research, Medical Devices, Supply Chain, Quality, Operations, PMA, 510K, regulatory
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Vice President Clinical AffairsMivi Neuroscience, IncScarsdale, Ny, Us -
Vice President Clinical AffairsSafeheal Oct 2024 - Present -
Vice President, Clinical And RegulatoryMivi Neuroscience, Inc Jun 2022 - Oct 2024Eden Prairie, Mn, Us• Lead the Global Clinical study Strategy and execution of IDE trials in the neurovascular space for aspiration catheter technologies to treat acute ischemic stroke and develop Regulatory strategies for bringing new products to market• Completed enrollment two months early in aspiration catheter trial -
Vice President Clinical And Regulatory AffairsMivi Neuroscience, Inc Jun 2022 - Sep 2024Eden Prairie, Mn, UsMIVI Neuroscience is an innovative small medical device company developing technology to provide better treatment options for patients experiencing acute ischemic stroke (AIS)• Support notified body and regulatory audits, primary point of contact for all regulatory interactions. Submitted 510k December 2023• Lead EU MDR conversion strategy for product portfolio, including identifying gaps and remediation efforts, and lead GDPR strategy to ensure compliance with regulations -
Senior Director, Peripheral Vascular HealthMedtronic Jan 2021 - Jun 2022Minneapolis, Mn, UsLead the Global Clinical Research function across the Peripheral Vascular Health operating unit, including managing an extended team of 40, and a global budget of $17M in project spend and a total of 12 active trialsPartner with cross-functional stakeholders to align on Clinical evidence gaps and research strategies, including physician-initiated, Medtronic sponsored trials, and collaborative research -
Director, Endovenous Clinical DepartmentMedtronic Aug 2020 - Jan 2021Minneapolis, Mn, UsLead Clinical strategy and Operational Execution of all endoVenous trials, including those that span the superficial, deep and embolization space. -
Clinical Research Director, Cardiac And Vascular Group ClinicalMedtronic Jun 2017 - Aug 2020Minneapolis, Mn, UsManaged the Aortic Clinical group in delivering on product portfolio, including developing Clinical study strategy and execution.Assessed performance of the Centers for Research Innovation (CRI) hospitals, field personnel workload, and co-developed team branding and workforce planning for next 5 years.Delivered on the 5 year CVG Clinical strategy, with a particular focus on Value Based Health Care, Lean Sigma, and Analytics initiatives. -
Cardiac And Vascular Group Senior Field Clinical ManagerMedtronic May 2015 - Jun 2017Minneapolis, Mn, UsManage team of 8 Clinical Account Leaders who oversee clinical research at a select number of Clinical strategic partners across the Eastern half of the US. Manage $2.5M annual budget, training plans, annual national meeting planning, hiring, promotions, quarterly reviews and development conversations, and performance improvement plans.Drive key metrics of speed to study completion & ensuring high data quality across the Cardiac and Vascular Group studies.Co-led a global initiative for harmonizing Standard Operating Procedures into a single global version across all Clinical Business Units.Drive Account Management strategy across the Cardiac and Vascular Group portfolio. Serve as Customer Contact for Clinical Research Pipeline and Portfolio. -
Field Clinical ManagerMedtronic Jul 2012 - May 2015Minneapolis, Mn, UsManaged a team of 11 Field Clinical Research Specialists who work with 68 clinical research centers across the Northeastern US. Managed hiring, retention, promotion, and annual performance reviews. -
Sr. Technical Field EngineerMedtronic Apr 2011 - Jul 2012Minneapolis, Mn, UsTrained physician customers and field sales teams on new product technology.Served as technical expert & clinical resource on all cardiac rhythm products and new publications.Assisted physicians in the operating room and electrophysiology lab by providing troubleshooting recommendations. -
Operations Rotational ProgramMedtronic Jul 2009 - Apr 2011Minneapolis, Mn, UsManaged field action: Led global team, developed communication strategy & timeline, and implemented proposed plan.Created gap analysis on current Product Hold Order process. Created corrective action plan to improve field compliance.Developed analysis of product reliability across the industry using data from product performance reports.Created the inventory launch strategy for a new product line. Partnered with marketing, sales, sourcing, manufacturing and distribution to identify inventory needs for worldwide product launch. Led inventory initiative by identifying customer needs and analyzed how RFID can manage field inventory -
Graduate Administrative InternNorthwestern Memorial Hospital Jun 2008 - Aug 2008Chicago, Il, UsManaged a project to categorize discrepancies in billing and purchasing, identified $1M of potential billing opportunities within Surgical Services. -
Senior Field Clinical EngineerMedtronic Apr 2004 - Aug 2007Minneapolis, Mn, UsManaged pre-market clinical studies for 7 hospitals in New York and Vermont. Nominated new investigators and helped with oversight of patient enrollment, hospital activation, and follow-up visits.Trained physicians on study protocols, device programming requirements and experimental technology. -
Clinical SpecialistMedtronic Mar 2003 - Apr 2004Minneapolis, Mn, UsProgrammed cardiac devices at patient follow-up clinics and in operating rooms.Educated allied health professional staff through Albany office classes and in-service programs. -
Biomedical EngineerGe Aug 2001 - Mar 2003Boston, Ma, UsCertified as Six Sigma Green Belt.Researched and studied the effect of neurodegenerative diseases on brain volume and metabolite concentration using magnetic resonance spectroscopy (MRS). Proficient in programming using LabView.Designed a data acquisition and analysis program in LabVIEW that calculates material characteristics used in medical ultrasound probes.Completed Advanced Course in Engineering and leadership training course at Crotonville.
Heather Cronin Skills
Heather Cronin Education Details
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Mit Sloan School Of ManagementBusiness Administration -
Rensselaer Polytechnic InstituteElectrical Concentration
Frequently Asked Questions about Heather Cronin
What company does Heather Cronin work for?
Heather Cronin works for Mivi Neuroscience, Inc
What is Heather Cronin's role at the current company?
Heather Cronin's current role is Vice President Clinical Affairs.
What is Heather Cronin's email address?
Heather Cronin's email address is he****@****nic.com
What is Heather Cronin's direct phone number?
Heather Cronin's direct phone number is (800) 633*****
What schools did Heather Cronin attend?
Heather Cronin attended Mit Sloan School Of Management, Rensselaer Polytechnic Institute.
What skills is Heather Cronin known for?
Heather Cronin has skills like Medical Devices, Biomedical Engineering, Clinical Research, Healthcare, Product Launch, Hospitals, Strategy, Product Development, Leadership, Operating Room, Supply Chain, Clinical.
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