Michael Mach Email and Phone Number
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Experienced Senior Regulatory Affairs Specialist with a demonstrated history of working in the medical device industry. Skilled in 21 CFR, U.S. Food and Drug Administration (FDA), Corrective and Preventive Action (CAPA), Regulatory Submissions, and CE marking under MDD/MDR. I possess a Master's degree focused in Regulatory Affairs and Services from St. Cloud State University.
Innovia Medical
View- Website:
- innoviamedical.com
- Employees:
- 82
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Sr. Regulatory Affairs SpecialistInnovia MedicalMinneapolis, Mn, Us
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Senior Regulatory SpecialistMedtronic Jan 2021 - PresentMinneapolis, Mn, Us -
Senior Regulatory Affairs SpecialistZirc Dental Products Jan 2020 - Dec 2020Buffalo, Mn, Us -
Senior Regulatory Affairs SpecialistRti Surgical® Jun 2018 - Jan 2020Alachua, Fl, Us -
Compliance ManagerPinnacle Climate Technologies Sep 2016 - Jun 2018Sauk Rapids, Mn, UsResponsible for CE marking of comfort products, assuring compliance to necessary directives and regulations. Assure manufacturing process remains compliant through detailed review of manufacturing documentation. Work with third-party test agencies to assess need to updates of product registrations. Worked with Saudi regulatory authority for understanding device specific regulatory requirements. Review associated labeling for compliance. -
Regulatory Affairs SpecialistMedtronic Jun 2014 - Aug 2016Minneapolis, Mn, UsResponsibilities included 510(k) submission, Change Notices, heavily involved in re certification project, regulatory lead in packaging remediation project. Worked as part of cross functional teams to understand product changes and assessed for reportability. Worked with Class II Combination Products in US and Class III products in EU. Worked within multiple geographies to assess product changes. Working knowledge of Technical Files, Design Dossiers. Review of labeling and promotional materials assuring adherence to established company policies as well as regulations.
Michael Mach Skills
Michael Mach Education Details
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St. Cloud State UniversityRegulatory Affairs And Services -
St. Cloud State UniversityGeneral
Frequently Asked Questions about Michael Mach
What company does Michael Mach work for?
Michael Mach works for Innovia Medical
What is Michael Mach's role at the current company?
Michael Mach's current role is Sr. Regulatory Affairs Specialist.
What is Michael Mach's email address?
Michael Mach's email address is mm****@****cal.com
What schools did Michael Mach attend?
Michael Mach attended St. Cloud State University, St. Cloud State University.
What skills is Michael Mach known for?
Michael Mach has skills like Regulatory Submissions, U.s. Food And Drug Administration, 510 Submissions, Capa, 21 Cfr, Ce Marking.
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