Senior Manager - Device Development
Current
Apr 2021 - Present
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Jayanthi M Email & Phone Number
Senior Manager - Strategy & Medical Device Development for combination products - USFDA, EMA & Global Markets
at
OneSource
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✓ Verified May 2026
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Profile completeness 86%
Current company
Role
Senior Manager - Strategy & Medical Device Development for combination products - USFDA, EMA & Global Markets
Location
Bengaluru, Karnataka, India
Who is Jayanthi M? Overview
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Jayanthi M is listed as Senior Manager - Strategy & Medical Device Development for combination products - USFDA, EMA & Global Markets at OneSource, based in Bengaluru, Karnataka, India. AeroLeads shows a matched LinkedIn profile for Jayanthi M.
Jayanthi M previously worked as Senior Manager - Device Development at Onesource and Patent Professional at Arcolab Private Limited. Jayanthi M holds M.Sc., Chemistry from Madurai Kamaraj University.
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OneSource
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Profile bio
About Jayanthi M
* Seasoned Medical Device (Combination Products) Professional & Patent Professional having more than 15 years of experience with specialization in medical device development strategy and intellectual property strategy for bio-pharmaceutical products including biologics and peptides.* Driving Medical Device Development Programs for domestic and global markets with a special focus on US and European markets* Responsible for Drafting and finalizing regulatory packages for Device Development Strategy, Questions to be clarified from the regulatory agencies and the responses to the queries received from regulatory agencies* Responsible for completion of Threshold Analysis and Human Factors Studies of drug device combination products including disposable & reusable pen injectors as per EU/US requirements.* Co-ordinate with device manufacturers, obtain all the device development documents including design verification, validation reports, evaluate and ensure the adequacy of the documents as per regulatory requirements* Expertise in Patent Portfolio Management, Patent landscaping, Patentability & Invalidation search, Patent applications drafting & filing, responding to office actions and trademark application filing
Current workplace
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8 roles
Jayanthi M work experience
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Patent Professional
Jul 2019 - Mar 2021
Patent Professional
Gopakumar Nair Associates (Stelis Biopharma)
Preparing written opinions on patentability, patent infringement and patent validity in order to minimize the business risksFreetom To Operate opinion & third party patent opinion for Biosimilar molecules Patent Due diligenceProviding Patentability opinion for Biosimilar products with respect to process (USP & DSP) & pharmaceutical compositions including.
Oct 2016 - Jun 2019
Ipr Professional
Acebright Pharmaceuticals
Preparing Prior Art Search reports for generic molecules and helping our researchers for the evaluation of patentability and non-infringing processes.Preparing freedom to operate (FTO) analysis reports by analyzing the validity of patents and patent landscaping for generic molecules.Carefully monitoring competitor's patent related activities & alerting our.
Jul 2013 - Oct 2016
Patent Attorney
De Penning & De Penning
Patent Administration, Patent Applications drafting, filing, prosecuting and taking necessary office actions of our esteemed clients
Apr 2013 - Jul 2013
Assistant Manager - Intellectual Property Management & Registered Patent Agent
Registered Patent Agent, IndiaDrafted and filed around 30 Indian patent applications (Provisional and Complete), 4 PCT patent applications and one pre-grant opposition.Preparing Prior Art Search reports for biosimilar and generic molecules and helping our researchers for the evaluation of patentability and non-infringing process and formulation.Managing.
Oct 2004 - Feb 2013
Jan 2003 - Sep 2004
Teacher
Modern Matriculation Higher Secondary School
Taught high school Physics, Chemistry, Biology
Jan 2002 - Dec 2002
4 education records
Jayanthi M education
M.Sc., Chemistry
M.B.A., Intellectual Property Rights
National Institute Of Management
Pgdpl, Patents Law
Nalsar University Of Law
B.Sc., Chemistry
FAQ
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Quick answers generated from the profile data available on this page.
What company does Jayanthi M work for?
Jayanthi M works for OneSource.
What is Jayanthi M's role at OneSource?
Jayanthi M is listed as Senior Manager - Strategy & Medical Device Development for combination products - USFDA, EMA & Global Markets at OneSource.
Where is Jayanthi M based?
Jayanthi M is based in Bengaluru, Karnataka, India while working with OneSource.
What companies has Jayanthi M worked for?
Jayanthi M has worked for Onesource, Arcolab Private Limited, Gopakumar Nair Associates (Stelis Biopharma), Acebright Pharmaceuticals, and De Penning & De Penning.
How can I contact Jayanthi M?
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What schools did Jayanthi M attend?
Jayanthi M holds M.Sc., Chemistry from Madurai Kamaraj University.
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