Senior Associate
Current
Apr 2023 - Present
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Shubham Kumar Email & Phone Number
Regulatory Affairs Associate @Freyr Solutions | Medical Device, IVD, SaMD | USFDA, CDSCO, ARTG, MDA, CE Marking, SAHPRA, Thai FDA| GATE'21 AIR 209
at
Freyr Solutions
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✓ Verified August 2026
3 data sources
Profile completeness 86%
Current company
Role
Regulatory Affairs Associate @Freyr Solutions | Medical Device, IVD, SaMD | USFDA, CDSCO, ARTG, MDA, CE Marking, SAHPRA, Thai FDA| GATE'21 AIR 209
Location
Jalandhar, Punjab, India
Company size
Who is Shubham Kumar? Overview
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Quick answer
Shubham Kumar is listed as Regulatory Affairs Associate @Freyr Solutions | Medical Device, IVD, SaMD | USFDA, CDSCO, ARTG, MDA, CE Marking, SAHPRA, Thai FDA| GATE'21 AIR 209 at Freyr Solutions, a with 718 employees, based in Jalandhar, Punjab, India. AeroLeads shows a matched LinkedIn profile for Shubham Kumar.
Shubham Kumar previously worked as Senior Associate at Freyr Solutions and Regulatory Affairs Associate at Freyr Solutions. Shubham Kumar holds Bachelor'S, Science And Technology [Biomedical Engineering], 81.0% from Lovely Professional University.
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Freyr Solutions
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Profile bio
About Shubham Kumar
As a Senior Associate at Freyr Solutions, I lead and support various regulatory affairs projects for medical device manufacturers in different markets, such as the US, EU, India, and Australia. I have a strong track record of obtaining regulatory approvals and certifications for multiple clients, such as CDSCO import licenses, CE Marking certificates, ARTG listings, and FDA clearances. I ensure compliance with the relevant standards and regulations, such as ISO 13485:2016, EU MDR 2017/745, and USFDA 21 CFR 820, by writing and reviewing quality and regulatory documents, such as DMFs, PMFs, SOPs, and technical files. (50 tokens)I have a Bachelor's degree in Biomedical Engineering from Lovely Professional University, where I also developed a strong interest and skill in machine learning. I apply this domain expertise to enhance the detection and diagnosis of Alzheimer's disease, a prevalent and incurable neurodegenerative disease. I have published a review article on this topic in the Journal of Interdisciplinary Cycle Research, and I have completed Google's Data Analyst Certificate. I am passionate about using data and technology to improve healthcare outcomes and quality. I am open to travel, relocate, and learn new skills and domains.
Current workplace
Shubham Kumar's current company
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Freyr Solutions
6 roles
Shubham Kumar work experience
A career timeline built from the work history available for this profile.
Regulatory Affairs Associate
1. Project 1 - Led Import License project for US-based Class B, C, and D medical device manufacturer in order to obtain a CDSCO import licence (MD - 14). Device Classification, the creation of administrative papers, DMF, Predicate Analysis, PMF, the compiling of technical documents, and the uploading of documents to the Sugam Portal were all part of the operations.2. Project 2 - The technical support provided to Israel based Medical Device manufacturer. The activities include Gap Assessment & remediation of Technical File as per EU MDR 2017/745 and remediation of Quality Assurance Procedures as per ISO 13485:2016, EU MDR 2017/745 and resolving non-conformities raised by Notified Body.3. Project 3 - Led project for Indian SaMD (IVD) manufacturer for CE Marking where range activities include Gap Assessments as per recognized concenses standards (ISO 62366, IEC 62304, ISO 14971 etc.), Drafting Technical File as per EU IVDR (2017/746).
Apr 2022 - Mar 2023
Junior Associate - Medical Devices
1. Assisting a customer with the strategic preparation and implementation of a quality management system (QMS) and regulatory submissions for their business.2. Preparing SOPs and other requirements in accordance with ISO 13485:2016, USFDA 21 CFR 820, and the Indian Fifth Schedule for medical devices, IVD's, SaMD.
Jun 2021 - Mar 2022
Student Mentor
Mentorient
Aug 2020 - May 2021
Product Developer
Synapso Private Limited
Working as product development trainee at Synapso Pvt. Ltd. Startup by IIIT Allahabad Students Incubate at lab CC3 5503. I am working on wearable patient monitoring system with SOS Feature in built in it.
Jun 2019 - Jul 2019
Summer Internship
After completion of my first year. I joined 4-week of training in hospital under biomedical field. To, enhance my practical knowledge.
Jun 2018 - Jul 2018
Team & coworkers
Colleagues at Freyr Solutions
Other employees you can reach at freyrsolutions.com. View company contacts for 718 employees →
RV
Rukmani Vaidyanathan
Colleague at Freyr SolutionsBengaluru, Karnataka, India
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SD
Sharatchandra Deshpandeu
Colleague at Freyr SolutionsHyderabad, Telangana, India
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SK
Saritha Kemidi
Colleague at Freyr SolutionsHyderabad, Telangana, India
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AM
Afroz Mohammed
Colleague at Freyr SolutionsHyderabad, Telangana, India
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PR
Paramesh Ragala
Colleague at Freyr SolutionsHyderabad, Telangana, India
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ND
Nitya Dwivedi
Colleague at Freyr SolutionsHyderabad, Telangana, India
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AI
Abdul Irfan Mohammed
Colleague at Freyr SolutionsHyderabad, Telangana, India
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LI
Lorena I Espinosa Orozco
Colleague at Freyr SolutionsBogotá D.C. Metropolitan Area, Colombia
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PS
P. Sivani Rao
Colleague at Freyr SolutionsHyderabad, Telangana, India
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DY
Diksha Yeole
Colleague at Freyr SolutionsMumbai, Maharashtra, India
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Rukmani Vaidyanathan
Colleague at Freyr SolutionsBengaluru, Karnataka, India
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SD
Sharatchandra Deshpandeu
Colleague at Freyr SolutionsHyderabad, Telangana, India
View →
SK
Saritha Kemidi
Colleague at Freyr SolutionsHyderabad, Telangana, India
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AM
Afroz Mohammed
Colleague at Freyr SolutionsHyderabad, Telangana, India
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PR
Paramesh Ragala
Colleague at Freyr SolutionsHyderabad, Telangana, India
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ND
Nitya Dwivedi
Colleague at Freyr SolutionsHyderabad, Telangana, India
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AI
Abdul Irfan Mohammed
Colleague at Freyr SolutionsHyderabad, Telangana, India
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LI
Lorena I Espinosa Orozco
Colleague at Freyr SolutionsBogotá D.C. Metropolitan Area, Colombia
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PS
P. Sivani Rao
Colleague at Freyr SolutionsHyderabad, Telangana, India
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DY
Diksha Yeole
Colleague at Freyr SolutionsMumbai, Maharashtra, India
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2 education records
Shubham Kumar education
Bachelor'S, Science And Technology [Biomedical Engineering], 81.0%
Senior Secondary, General Studies, A+
C.J.S Public School
FAQ
Frequently asked questions about Shubham Kumar
Quick answers generated from the profile data available on this page.
What company does Shubham Kumar work for?
Shubham Kumar works for Freyr Solutions.
What is Shubham Kumar's role at Freyr Solutions?
Shubham Kumar is listed as Regulatory Affairs Associate @Freyr Solutions | Medical Device, IVD, SaMD | USFDA, CDSCO, ARTG, MDA, CE Marking, SAHPRA, Thai FDA| GATE'21 AIR 209 at Freyr Solutions.
Where is Shubham Kumar based?
Shubham Kumar is based in Jalandhar, Punjab, India while working with Freyr Solutions.
What companies has Shubham Kumar worked for?
Shubham Kumar has worked for Freyr Solutions, Mentorient, Synapso Private Limited, and Shrimann Superspeciality Hospital.
Who are Shubham Kumar's colleagues at Freyr Solutions?
Shubham Kumar's colleagues at Freyr Solutions include Rukmani Vaidyanathan, Sharatchandra Deshpandeu, Saritha Kemidi, Afroz Mohammed, and Paramesh Ragala.
How can I contact Shubham Kumar?
You can use AeroLeads to view verified contact signals for Shubham Kumar at Freyr Solutions, including work email, phone, and LinkedIn data when available.
What schools did Shubham Kumar attend?
Shubham Kumar holds Bachelor'S, Science And Technology [Biomedical Engineering], 81.0% from Lovely Professional University.
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