7 July, 2022
Tata Elxsi is looking for Post Marketing surveillance – PMS Specialists and Clinical evaluation reports (CERs) Writing specialist
Experience: required-3-6 years
Write clinical evaluation reports (CERs) and post market surveillance summaries for CE marked devices
Work with internal teams to gain cross-functional inputs and approvals
Support periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives.
Develop and manage CER project plans and timelines.
Plan and deliver intra-departmental and cross-functional communication to ensure critical information is transmitted to relevant parties in a timely manner.
Perform periodic reviews of risk documentation, product labeling, and marketing claims as part of the clinical evaluation process.
Perform comprehensive literature searches to support assigned product lines.
Participate in audits
Consistently apply applicable global regulations and guidelines, as well as Cardinal Health policies and procedures
Assist in development of processes
Provide clinical review/approval of marketing materials
Maintain and update spreadsheets tracking the status for CER projects
Collect and maintain all documents necessary to ensure compliance with SOP
May manage contract writers
May support registration of products in non-EU countries
Proven experience performing literature reviews, analyzing data and communicating outputs.
Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.
Experience writing scientific documents for regulatory or journal submissions
Experience presenting scientific/clinical evidence in a written and oral manner to cross-functional teams.
Demonstrated ability to build positive constructive relationships with cross-functional team members
Demonstrated high level of personal integrity, emotional intelligence, flexibility
Extensive knowledge of MDD, MDR and MEDDEV requirements
Excellent scientific writing skills
Experience creating and performing literature searches in Embase, PubMed and Google Scholar
Experience using Microsoft Word, Excel, PowerPoint.
Strong data extraction and analysis skills
Proactive with a sense of urgency in managing job responsibilities
Self-motivated and able to work independently.
Analytical thinking and inquisitive mindset
Ability and desire to develop good working relationships internally and externally.
Skills and qualifications required-
· B.E./B.Tech /M. Pharma/B. Pharma/Bio-medical engineer.
· EU MDR or other regulatory bodies compliance & regulatory writing experience
· Medical writing/ Scientific writing criteria/ Narrative writing experience PMS
. EU MDR and Regulatory Affairs(Medical Devices) is preferred.
Please connect with Namrata Harihar (Engineer at Tata Elxsi) on LinkedIn and share your CV.