Anu Mohan
@anumohan
Regulatory affairs specialist experienced in global medical device and SaMD registrations and compliance.
South KoreaWhat I'm looking for
I am a Regulatory Affairs Specialist with 14 years' experience driving global product registrations, regulatory strategy, and compliance for medical devices and Software as a Medical Device (SaMD). I have established regulatory teams, led submissions across major markets (EU MDR, US FDA, China NMPA and others), and delivered conformity and labeling artifacts while supporting audits and QMS alignment.
I combine technical background in networking and systems with regulatory expertise to enable faster market entry, provide cross-functional leadership, and implement process improvements. I have led regulatory teams, supported cybersecurity and post-market activities, and received internal awards for quality and regulatory excellence.
Experience
Work history, roles, and key accomplishments
SHEstablished and led a cross-business-line regulatory affairs team supporting D&A products, drove global regulatory submissions (EU MDR, FDA 510(k), NMPA, TGA, MFDS, etc.), and delivered compliance artifacts that enabled timely market entries across multiple regions.
MISenior Engineer - IMTS
Mindtree
May 2013 - Aug 2015 (2 years 3 months)
Provided L1/L2 application support for Cisco Smart Care Services, managed incidents through Case Monitor/Web Monitor/Remedy, performed device testing and RMA processing, and coordinated with L3 teams to meet SLA targets.
Customer Engineer - Network Administrator
HCL Infosystems
Aug 2008 - Apr 2013 (4 years 8 months)
Managed L2 network administration for national backbone and GSM/MPLS projects at BSNL, led multi-state engineering teams, performed IOS upgrades, monitoring, backups and delivered high-availability network operations.
Education
Degrees, certifications, and relevant coursework
SBSymbiosis Institute of Business Management, Bengaluru
Master of Business Administration (Executive), Business Administration
2015 - 2017
Activities and societies: Academic Excellence Award 2017; leadership and soft-skills trainings.
Executive MBA focused on management practices and leadership, completed as batch topper (Rank 1) for the E-MBA 2018 cohort.
UCUniversity of Calicut
Bachelor of Technology, Electronics and Communication Engineering
2004 - 2008
Bachelor of Technology in Electronics and Communication, covering core engineering subjects and telecommunications fundamentals.
Tech stack
Software and tools used professionally
Availability
Location
South KoreaAuthorized to work in
Job categories
Skills
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