Anu Mohan
@anumohan1
Regulatory affairs professional leveraging global submissions and quality mindset to accelerate medical device compliance.
South KoreaWhat I'm looking for
I’m a Regulatory Affairs Professional with experience across healthcare and medical device regulation, with a strong foundation in quality and operational excellence. I’ve built and supported regulatory capabilities and helped teams ramp up through structured trainings and clear execution frameworks.
At Siemens Healthineers, I’ve driven regulatory strategy and execution for D&A products, including regulatory assessments, conformity assessment for EU compliance, and deliverables like Regulatory compliance plan, Product labeling specification, GSPRC, DOC, and STED. I support global submissions spanning EU MDR/MDD, US 510k, China NMPA, and other regions, while collaborating across teams to enable faster market entry.
I also support regulatory impact assessment work tied to TRSM and ensures changes are implemented in the QMS, with additional cybersecurity deliverables support for regulatory submissions. Earlier, I contributed to quality initiatives at SYNGO and brought hands-on technical depth from my network engineering background, including CCNA, IT infrastructure, and network security.
Experience
Work history, roles, and key accomplishments
Set up and led a regulatory affairs team from scratch to support cross-business lines, driving operational planning, recruiting, and training for QMS handling. Managed global medical device regulatory submissions and compliance deliverables including EU MDR/MDD, US 510(k), and China NMPA, and supported regulatory impact implementation in the QMS.
Senior Engineer IMTS
Mindtree
May 2013 - Aug 2015 (2 years 3 months)
Provided end-to-end technical support for Cisco Smart Care services, handling Sev 1–4 cases and coordinating with worldwide Cisco teams for faster case resolution. Used Remedy, CaseMon, WebMon, and Cisco Webex to manage cases and collaborate across support groups.
Network Engineer
HCL Infosystems Ltd
Aug 2009 - Apr 2013 (3 years 8 months)
Configured and maintained client networks for BSNL, including IP addressing, router implementation, and troubleshooting using WhatsUp Gold and Wireshark. Implemented connectivity across 30 locations using 198 optical links, supported customer acceptance testing, and contributed network security configuration and firewall testing.
Education
Degrees, certifications, and relevant coursework
Symbiosis Institute of Business Management (SIBM) Bengaluru
Master of Business Administration (MBA), General Management
2015 - 2018
Completed an MBA at SIBM Bengaluru with specialization in CCNA Operations / General Management (as stated in the profile summary).
University of Calicut
Bachelor of Technology (B-Tech), Electronics and Communication Engineering
Completed a B-Tech in Electronics and Communication from the University of Calicut.
Mount Carmel Convent Anglo Indian Girls High School, Tangasseri, Kollam
Availability
Location
South KoreaAuthorized to work in
Portfolio
unveilyourthoughts.blogspot.comJob categories
Skills
Interested in hiring Anu?
You can contact Anu and 90k+ other talented remote workers on Himalayas.
Message AnuFind your dream job
Sign up now and join over 250,000+ remote workers who receive personalized job alerts, curated job matches, and more for free!
