Medical Device Subject Matter Expert
- Tech Mahindra
- 10 - 15 Years
- Gurgoan
- 5 years ago
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Job Description
- 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 organizations risk management processes
- Support regulatory submission projects with submission requirements for appropriate market and product type
Education & Experience
Education:
- Masters 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
Employement Category:
Employement Type: Full timeIndustry: Bio Technology & Life SciencesFunctional Area: PharmaceuticalRole Category: Other PharmaRole/Responsibilies: Medical Device Subject Matter ExpertContact Details:
Company: Tech MahindraLocation(s): Gurgoan+ View Contact
Keyskills: Medical Device Subject Matter Exper MDR IVDR MDR gap analysis MDR compliant Clinical Evaluation
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Tech Mahindra
Netmagic, an NTT Communications company, is India’s leading Managed Hosting and Cloud service provider, with 9 carrier-neutral, state-of-the-art data centers and serving more than 2000 enterprises globally. Headquartered in Mumbai, Netmagic also delivers Remote Infrastructure Management (RIM) se...
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