Mari Meyer

Mari Meyer Email and Phone Number

Vice President, Regulatory and Clinical Affairs North America at DiaSorin Inc. @
Mari Meyer's Location
Stillwater, Minnesota, United States, United States
Mari Meyer's Contact Details

Mari Meyer personal email

n/a
About Mari Meyer

Experienced Regulatory and Clinical Affairs Executive with a demonstrated history of working in the biotechnology industry. Skilled in Verification and Validation (V&V), Good Laboratory Practice (GLP), Medical Devices, FDA GMP, and Oncology. Strong regulatory and clinical affairs professional.

Mari Meyer's Current Company Details
DiaSorin Inc.

Diasorin Inc.

Vice President, Regulatory and Clinical Affairs North America at DiaSorin Inc.
Mari Meyer Work Experience Details
  • Diasorin Inc.
    Vice President, Regulatory And Clinical Affairs, North America
    Diasorin Inc. Mar 1985 - Present
  • Diasorin
    Senior Director Ra And Qa
    Diasorin 2014 - Feb 2017
    Saluggia, Vc, It
    View
  • Diasorin
    Director, Regulatory Affairs
    Diasorin 2012 - Dec 2014
    Saluggia, Vc, It
    Senior regulatory representative responsible for all regulatory activities of private in vitro diagnostic manufacturing company producing clinical diagnostics and instruments.Manages a team of five regulatory staff and administrative personnel. Acts as resource and support for Quality Assurance department in inspections and compliance activities.Interacts directly with senior management of Italian parent company to coordinate new product regulatory submissions and activities.Responsible for ensuring positive FDA regulatory compliance profile and direct interaction and negotiation with US and Canadian regulatory authorities for all product changes and new product activities.Member of senior and management team for project planning and strategic development. Directly reports to President.
    View
  • Diasorin
    Senior Manager, Regulatory Affairs
    Diasorin 2008 - 2012
    Saluggia, Vc, It
    Lead regulatory affairs function to assure compliance with processes and obtain approvals of appropriate regulatory bodies to meet company goals and strategies. Correspond with governmental agencies, notified bodies, and/or foreign distributors to determine product registration requirements. Assure that products comply with United States and international in vitro diagnostic medical device and import/export regulations. Manage the conduct of clinical studies.
    View
  • Diasorin
    Regulatory/Clinical Affairs Specialist
    Diasorin 2002 - 2008
    Saluggia, Vc, It
    • Perform clinical site monitoring which includes but is not limited to performing site audits, training, maintenance, data review and close-outs• Preparation of 510(k) submissions• Instrumental in following the 510(k) submissions through to clearance• Compilation of technical documentation required to comply with EC Directive 98/79/EC (IVD Directive) and assembly of the Technical Files• Preparation of Canadian licenses (Class II and III)• Maintenance of Canadian product licensing (Class II and III) • Provide regulatory support for products already registered or licensed• Review ECO’s related to advertising and labeling
    View

Mari Meyer Skills

Regulatory Affairs Medical Devices Fda Validation Capa Ivd Hardware Diagnostics Biotechnology Fda Gmp Immunoassays Iso 13485 Gmp V&v Iso 14971 Life Sciences Infectious Diseases Immunology Regulatory Submissions U.s. Food And Drug Administration Design Control Lifesciences Quality System 21 Cfr Part 11 Glp Commercialization Sop Biomedical Engineering Technology Transfer Microbiology Quality Assurance Cross Functional Team Leadership Medical Diagnostics Laboratory Corrective And Preventive Action Oncology Pharmaceutical Industry Product Launch

Mari Meyer Education Details

  • Northwood Technical College
    Northwood Technical College
    Medical/Clinical Assistant
  • River Falls High School
    River Falls High School

Frequently Asked Questions about Mari Meyer

What company does Mari Meyer work for?

Mari Meyer works for Diasorin Inc.

What is Mari Meyer's role at the current company?

Mari Meyer's current role is Vice President, Regulatory and Clinical Affairs North America at DiaSorin Inc..

What is Mari Meyer's email address?

Mari Meyer's email address is ma****@****rin.com

What is Mari Meyer's direct phone number?

Mari Meyer's direct phone number is +165143*****

What schools did Mari Meyer attend?

Mari Meyer attended Northwood Technical College, River Falls High School.

What are some of Mari Meyer's interests?

Mari Meyer has interest in Social Services, Children, Environment, Education, Science And Technology, Disaster And Humanitarian Relief, Animal Welfare, Health.

What skills is Mari Meyer known for?

Mari Meyer has skills like Regulatory Affairs, Medical Devices, Fda, Validation, Capa, Ivd, Hardware Diagnostics, Biotechnology, Fda Gmp, Immunoassays, Iso 13485, Gmp.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

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.