Maureen Mooney

Maureen Mooney Email and Phone Number

Medical Device Quality and Regulatory Affairs Professional @ RQM+
Maureen Mooney's Location
Greater Chicago Area, United States
Maureen Mooney's Contact Details

Maureen Mooney personal email

n/a

Maureen Mooney phone numbers

About Maureen Mooney

Regulatory Affairs professional with practical experience and a thorough understanding of the medical device industry. Proficient in European Union Medical Device Regulation (EU-MDR) and experienced in global regulatory affairs across Asia, North America, Latin America, and Europe. Expertise in leading regulatory submissions for EU, US, and international markets, and in life-cycle CE marking for Class I, II, and III devices. Skilled in developing regulatory strategies for product development and significant changes, maintaining Technical Files (Class I and II), and Design Dossiers (Class III). Experienced in managing applications to Notified Bodies and overseeing regulatory content for device labels for shipping, primary packaging, and IFUs/Operator Manuals across 80+ countries. Competent in conducting regulatory assessments for design changes and new product development.

Maureen Mooney's Current Company Details
RQM+

Rqm+

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Medical Device Quality and Regulatory Affairs Professional
Maureen Mooney Work Experience Details
  • Rqm+
    Principal
    Rqm+ Apr 2018 - Present
    View
  • Fresenius Kabi Usa
    Sr. Manager, Regulatory Affairs
    Fresenius Kabi Usa Mar 2013 - Mar 2018
    View
  • Iris Global, Llc
    Regulatory Affairs Consultant
    Iris Global, Llc Jun 2012 - Feb 2013
    View

Maureen Mooney Skills

Regulatory Affairs Fda Medical Devices Quality System Iso 13485 Quality Assurance Capa Gmp Design Control Ce Marking Iso Pma V&v Annual Reports Iso 14971 Sop Cross Functional Team Leadership Iso 9000 Medical Device Directive Regulatory Submissions Quality Systems 21 Cfr Part 11 Biotechnology Validation Pharmaceutical Industry Quality Auditing Change Control

Maureen Mooney Education Details

Frequently Asked Questions about Maureen Mooney

What company does Maureen Mooney work for?

Maureen Mooney works for Rqm+

What is Maureen Mooney's role at the current company?

Maureen Mooney's current role is Medical Device Quality and Regulatory Affairs Professional.

What is Maureen Mooney's email address?

Maureen Mooney's email address is ma****@****ast.net

What is Maureen Mooney's direct phone number?

Maureen Mooney's direct phone number is +184755*****

What schools did Maureen Mooney attend?

Maureen Mooney attended Depaul University.

What skills is Maureen Mooney known for?

Maureen Mooney has skills like Regulatory Affairs, Fda, Medical Devices, Quality System, Iso 13485, Quality Assurance, Capa, Gmp, Design Control, Ce Marking, Iso, Pma.

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