Bio Medical Engineer Jobs in Bangalore - Elexes Medical Consulting

• ELEXES Medical Consulting offers you a challenging and rewarding job!
  
• You will be part of a growing data-focused Regulatory and Quality services team be able to work across a diverse portfolio of clients and international projects.
  

• As a member of the ELEXES team, you will be responsible to support company regulatory objectives in the maintenance of documentation and ensuring the utmost quality and accuracy at all the times.
  
• You need to use organizational skills and meticulous attention to detail to support regulatory projects. 
  
• Remember, overall you will be a key contributor to the continued success of all submissions to regulatory agencies.
  

Your Job Description

• You shall provide independent regulatory guidance to the clients to support optimal timelines for new/modified product launches.
  
• You will be responsible for coordinating efforts associated with Worldwide regulatory submission (e.g., 510k Submissions, FDA correspondences) as assigned.
  
• You will be responsible for executing regulatory strategies for projects.
  
• You will be also be asked to participate in RA related parts in-site audits and routine RA maintenance activities.
  
• You are expected to be aware of the current regulatory standards/regulations especially of US and European market. 
  
• You will be involved in the writing or updating of SOPs and work instructions with minimal supervision.
  
• You will be involved in the preparation of assessment, approval of communication material (IFU, leaflets, brochures) and development/improvement of RA related processes.
  
• Leverages a deep scientific and technical understanding of regulated products under the scope of responsibility to provide strategic guidance and support for portfolio and life-cycle management of products (for example, represents Regulatory in the product recall and recall communication process).
  
• Ensure to define and prioritize decision criteria and considers benefits, risks, and credo of each alternative before making decisions.
  
• Considers all the available facts when situations are ambiguous to make the best possible decision (for ex, when regulations are unclear).
  
• Your Job Requirements
  

Qualifications

• Bachelor degree in Biomedical Engineering from accredited college or University in science
  
• Master of Science in Biomedical engineering, preferred but not required.
  
• Experience:0-<1 year
  

Critical Skills/technical know-how

• Highly organized individual who is able to work under strict timelines
  
• Support regulatory compliance/Quality assurance
  
• Fluent in English
  
• Strong interpersonal skills and proactive working attitude
  
• Excellent writing and communication skills
  
• Competency to compose technical emails
  
• Execute regulatory strategy for assigned development projects
  
• Participate in cross-functional team discussions
  
• Create documents of the design control process
  
• Assess regulatory implications of change requests
  
• Review product related labeling and marketing material
  

• This job does not involve medical device design, testing, but is strictly restricted to regulations and quality systems documentation, advice and audits.