Dr. Akash Sharma

CEO

Mombasa, County, Kenya8 yrs 8 mos experience
Most Likely To SwitchHighly Stable

Key Highlights

  • Expert in navigating complex medical device regulations.
  • Authored over 40 research papers and 10 books.
  • Head of Regulatory Affairs at Revital Healthcare.
Stackforce AI infers this person is a Regulatory Affairs expert in the Healthcare industry.

Contact

Skills

Core Skills

Regulatory AffairsQuality ManagementRegulatory ComplianceResearch And Development

Other Skills

Regulatory Strategyquality management system 13485Project ManagementTeam ManagementLeadershipRegulatory PolicyRegulatory SubmissionsComplaint ManagementIVDDDesign DevelopmentProject TeamsCross-functional Team LeadershipLife SciencesClinical AssessmentClinical Data

About

I'm a seasoned Regulatory Affairs and Quality Management System professional specializing in medical devices. With expertise in navigating complex regulations like EUMDR, QMS (ISO13485), MDSAP, WHO-PQ, Risk Management, and GMP, I help companies achieve and maintain compliance. Currently, I serve as the Head of Regulatory Affairs & Quality Assurance at Revital Healthcare (EPZ) Limited in Kenya, leading a team to ensure regulatory compliance in the healthcare sector. My background includes a role as a Management Representative & Manager- Regulatory Affairs at Kaulmed Private Limited, and I've held key positions as a Research Engineer, Scientist-'C', and Quality Engineer. Academically, I hold M.Tech (ME). and Ph.D. (ME) degrees and have authored 40+ research papers and 10 books in the healthcare and regulatory field, positioning me as a thought leader committed to advancing knowledge and contributing to industry discourse.

Experience

8 yrs 8 mos
Total Experience
2 yrs 2 mos
Average Tenure
2 yrs 7 mos
Current Experience

Revital healthcare (epz) limited

Head of Quality & Regulatory Affairs

Nov 2023Present · 2 yrs 7 mos · Kenya · On-site

Regulatory AffairsRegulatory Strategyquality management system 13485Project ManagementTeam ManagementLeadership+1

Kaulmed

Regulatory Affairs Manager & Management Representative

Sep 2020Oct 2023 · 3 yrs 1 mo · SONEPAT, INDIA.

Regulatory PolicyRegulatory SubmissionsComplaint ManagementIVDDDesign DevelopmentProject Teams+19

auxein medical

Research Engineer

Aug 2020Sep 2020 · 1 mo · India

  • Research & Development
Design DevelopmentLife SciencesRegulatory ComplianceProduction EngineeringInterpersonal SkillsMedical Device Regulation (MDR)+2

Fare labs pvt. ltd.

Scientist 'C'

Jan 2019Aug 2020 · 1 yr 7 mos · Gurugram, Haryana, India

Interpersonal SkillsSingle Audit

Munjal kiriu industries pvt. ltd.

Quality Assurance Engineer

Jan 2016Jun 2017 · 1 yr 5 mos · India

Interpersonal Skills

Atul group of industries

Trainee Engineer

Jun 2014Aug 2014 · 2 mos

Interpersonal Skills

Education

GLA University

Doctor of Philosophy - PhD — Mechanical Engineering

Aug 2019Aug 2022

GLA University

Master of Technology - MTech — Mechanical Engineering

Aug 2017Aug 2019

Uttrakhand Technical University, Dehradun

Bachelor of Technology (B.Tech.) — Mechanical Engineering

Jan 2012Jan 2016

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