Regulatory affairs professional for a leading medical device company
Lowell, Massachusetts
AngioDynamics
Specialist, Global Regulatory Affairs
May 2012 to May 2018
Marlborough, MA
Sirtex Medical Limited
Senior Regulatory Affairs Specialist
Woburn, Massachusetts
Mitralign Inc.
Senior Regulatory Affairs Specialist
May 2018 to November 2018
Tewksbury, Massachusetts
Navilyst Medical, Inc.
Regulatory Affairs Specialist + Internship
June 2010 to April 2012
Marlborough, MA
Work with all customers within our industry to coordinate, compile and organize information necessary for preparation of regulatory documentation packages that will be forwarded to Regulatory Agencies (FDA, EU, Canada, EMEA, APAC, LatAM) to obtain the clearance and marketing authorization of medical devices. Update and maintain regulatory files; learn to all relevant regulatory/legal requirements for introduction and... Work with all customers within our industry to coordinate, compile and organize information necessary for preparation of regulatory documentation packages that will be forwarded to Regulatory Agencies (FDA, EU, Canada, EMEA, APAC, LatAM) to obtain the clearance and marketing authorization of medical devices. Update and maintain regulatory files; learn to all relevant regulatory/legal requirements for introduction and maintenance of medical devices throughout a product's lifecycle to remain compliant.
What company does Michael Hanley work for?
Michael Hanley works for AngioDynamics
What is Michael Hanley's role at AngioDynamics?
Michael Hanley is Specialist, Global Regulatory Affairs
What industry does Michael Hanley work in?
Michael Hanley works in the Medical Devices industry.
📖 Summary
Specialist, Global Regulatory Affairs @ AngioDynamics Work with all customers within our industry to coordinate, compile and organize information necessary for preparation of regulatory documentation packages that will be forwarded to Regulatory Agencies (FDA, EU, Canada, EMEA, APAC, LatAM) to obtain the clearance and marketing authorization of medical devices. Update and maintain regulatory files; learn to all relevant regulatory/legal requirements for introduction and maintenance of medical devices throughout a product's lifecycle to remain compliant. From May 2012 to May 2018 (6 years 1 month) Marlborough, MASenior Regulatory Affairs Specialist @ Sirtex Medical Limited Woburn, MassachusettsSenior Regulatory Affairs Specialist @ Mitralign Inc. From May 2018 to November 2018 (7 months) Tewksbury, MassachusettsRegulatory Affairs Specialist + Internship @ Navilyst Medical, Inc. Aiding in regulatory and consultation services.- registration and distribution of product.- carrying out negotiations necessary to obtain and maintain marketing authorization for the product requested by global regulatory and distribution partners.- utilizing and creating important reports and technical documentation maintaining /creating critical databases tracking approved product and licenses from domestic to international cliental. From June 2010 to April 2012 (1 year 11 months) Marlborough, MA
Introversion (I), Intuition (N), Feeling (F), Perceiving (P)
2 year(s), 10 month(s)
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Likely
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