Medical Device Subject Matter Expert

Medical Device Subject Matter Expert

Tech Mahindra Limited
Hyderabad / Secunderabad
10-15 years
Not Specified

Job Description

Job Description:

Roles & Responsibilities:
  • Provide advisory consulting services, proactively monitor regulations across regions to advise clients on new regulations
  • Provide SME consulting for Regulatory compliance according to the current EU Directives (i.e. MDD & IVD), new EU Regulations MDR & IVDR (EU 2017/745 & EU 2017/746), FDA, ANVISA, Heath Canada, MHLW/PMDA & TGA (MDSAP requirements)
  • Lead MDR gap analysis projects and conduct analysis of existing systems, processes and departments in terms of new regulation
  • Implement improvements to technical files and other documents like Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER)
  • Understand current compliance situation of medical device to international standards
  • Suggest and support implementation of changes to organization’s risk management processes
  • Support regulatory submission projects with submission requirements for appropriate market and product type

Education & Experience

Education:
  • Master’s degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields.
  • RAC certification: Medical Devices is a plus

Experience:
  • Minimal 10 years working experience in the field of medical devices through positions in industry, consultancy or regulatory agencies (Notified Bodies, FDA, EMA), in either manufacturing, R&D, quality or regulatory roles
  • Experience writing MDR compliant Clinical Evaluation Reports and other documents
  • Knowledge of Quality Management Systems implementation to ISO 13485:2016
  • Knowledge of Risk Management Systems based on ISO 14971:2012
  • Experience in creating customer facing materials and conducting workshops as SME
  • Knowledge of Medical Device Regulations related to major health authorities of US, EU, Japan, China, Australia, Brazil, Canada
  • Worked in a client-focused organization as a consultant in the past
  • Hands on experience in managing all regulatory affairs activities and ensuring full regulatory compliance for medical devices

Tech Mahindra represents the connected world, offering innovative and customer-centric information technology experiences, enabling Enterprises, Associates and the Society to Rise™. We are a USD 4.7 billion company with 115,200+ professionals across 90 countries, helping over 903 global customers including Fortune 500 companies. Our convergent, digital, design experiences, innovation platforms and reusable assets connect across a number of technologies to deliver tangible business value and experiences to our stakeholders. Tech Mahindra is amongst the Fab 50 companies in Asia (Forbes 2016 list).

We are part of the USD 19 billion Mahindra Group that employs more than 200,000 people in over 100 countries. The Group operates in the key industries that drive economic growth, enjoying a leadership position in tractors, utility vehicles, after-market, information technology and vacation ownership

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