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Experienced medical device compliance professional and manager. Knowledgeable in all aspects of product development, deployment and post launch monitoring. I enjoy learning about new medical technologies and using my skills and experience to help companies navigate the compliance landscape and realize goals.ASQ senior member and Certified Manager of Quality/Organizational ExcellenceRAPS memberISO13485:2003 Lead Auditor (TPECS)Specialties: Regulatory and quality system compliance management solutions for the medical device industry. Significant experience in the regulatory and quality systems in the USA, Canada, Europe and Australia. Also expierenced in several Aisan markets including Japan, China and Korea.
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Regulatory AffairsAbbott Mar 2021 - PresentAbbott Park, Illinois, Us -
Director Regulatory AffairsAusculsciences Jun 2016 - Mar 2021Ottawa, On, CaRegulatory compliance at a cardiovascular device manufacturer. -
Regulatory Affairs Project ManagerAbbott Point Of Care Aug 2013 - Jun 2016Abbott Park, Illinois, UsGlobal regulatory submissions and registrations for point of care IVD systems. -
Compliance ManagerDna Genotek 2011 - Jul 2013Ottawa, On, CaManaging global medical device compliance systems for a leading biotechnology company. -
Regulatory ManagerDna Genotek 2009 - 2010Ottawa, On, CaEnsuring global medical device regulatory compliance. -
Quality Assurance And Regulatory Affairs ManagerCovidien 2005 - 2009Fridley, Minnesota, UsISO13485 CMDCAS, 21CFR820 compliance. Sleep Dx, Neuro Dx and respiratory clinical information software and systems. -
Regulatory Affairs AssociateTyco Healthcare (Became Covidien) 2002 - 2005Amsterdam, Noord-Holland, NlFDA, CMDR, MDD compliance work. Sleep diagnostic, neurodiagnostic and clinical information software and systems. -
Regulatory SpecialistThermo Fisher Scientific 2001 - 2002Waltham, Ma, UsManaging company's ISO90002/13488 QMS and compliance to many other requirements including transportation of dangerous goods (TDG), Environmental regulations, CSA electrical certification, MSDS/WHMIS, etc. Auditing instrument service group to ISO17025. -
Customer Service Supervisor - Western And EducationalThermo Fisher Scientific 2000 - 2001Waltham, Ma, UsManaging a team of 12-14 call center reps servicing Manitoba to BC and secondary school accounts. -
Industrial Safety CsrThermo Fisher Scientific 1999 - 2000Waltham, Ma, UsContract management and customer service to Ontario based industrial safety product clients. -
Customer Service RepresentativeThermo Fisher Scientific 1997 - 1999Waltham, Ma, UsServing a wide varitey of laboratory customers in Western Canada.
Rob Matheson Skills
Rob Matheson Education Details
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Algonquin College Of Applied Arts And TechnologyEnvironmental Technology Diploma (3 Year) -
University Of Toronto At ScarboroughEconomics And Mathematics -
Cape Breton UniversityEngineering -
Sydney Academy
Frequently Asked Questions about Rob Matheson
What company does Rob Matheson work for?
Rob Matheson works for Abbott
What is Rob Matheson's role at the current company?
Rob Matheson's current role is Regulatory Affairs at Abbott Point of Care.
What is Rob Matheson's email address?
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What is Rob Matheson's direct phone number?
Rob Matheson's direct phone number is +187042*****
What schools did Rob Matheson attend?
Rob Matheson attended Algonquin College Of Applied Arts And Technology, University Of Toronto At Scarborough, Cape Breton University, Sydney Academy.
What skills is Rob Matheson known for?
Rob Matheson has skills like Fda, Medical Devices, Quality System, Iso 13485, Quality Assurance, Regulatory Affairs, Biotechnology, Regulatory Submissions, Capa, Quality Management, Validation, Product Development.
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