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Bio Medical Engineer Jobs in Bangalore - Elexes Medical Consulting

Bio Medical Engineer
Elexes Medical Consulting
Bangalore(Bommanahalli)
M.Pham, ME/M.Tech(Bio-Medical /Bio-Technology Engg), BE/B.Tech(Bio-Medical /Bio-Technology Engg), MS, MSc(Bio-Chemistry, Bio-Tech, Microbiology), B.Pharm
Elexes Medical Consulting
Last Date 15 Jan 2018

Elexes Medical Consulting - Job Details

Date of posting: 16 Nov 17

  • 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.

Your tasks

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

Hiring Process : Written-test, Face to Face Interview, Telephonic Interview

About Elexes Medical Consulting

Elexes is an end to end regulatory consulting firm

SPECIALITIES: 

• 510(k),PMA, IDE Submissions
• FDA QSR and ISO 13485 compliance 
• Document control for medical device, drugs, and biologics
• Electrical safety, EMC, biocompatibility, sterilization assurance testing
• Performance, bench, verification and validation testing 
• Global registrations in over 20 countries 
• 21 CFR Parts 11, 20, 50, 56, 211, 801, 803, 806, 807, 812, 813, 814, 822, 870, 876
• Clinical study
• Human factors study 
• cGMP, cGLP, cGDP
• ANVISA, FDA, CFDA, CMDCAS, COFEPRIS, HSA, JPAL, KFDA, SFDA, TGA
• CAPA Investigations
• Design Controls & labeling 
• GHS CLP, REACH, RoHS, UDI, WEEE
• IVD and medical device development 
This posting is done directly & exclusively on Freshersworld.com. We do not entertain any unsolicited calls or enquiries from any consultants, other portals or TPOs. Notice: This recruitment is FREE. if the recruiter charges any fees, please write us info@freshersworld.com
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Elexes Medical Consulting recruiting Bio Medical Engineer fresher’s in Bangalore(Bommanahalli). The Elexes Medical Consulting vacancies for Bio Medical Engineer is filled through Written-test, Face to Face Interview, Telephonic Interview etc.
Elexes Medical Consulting jobs for fresher’s are very common in nature as the company recruits a lot of fresher’s every year based on the skills . The candidates with M.Pham, ME/M.Tech(Bio-Medical /Bio-Technology Engg), BE/B.Tech(Bio-Medical /Bio-Technology Engg), MS, MSc(Bio-Chemistry, Bio-Tech, Microbiology), B.Pharm are selected to full fill the vacancies in Engineer (Core, Non-IT) job field. The fresher’s applying for Bio Medical Engineer should have a degree or post-graduation in the required field based on the requirement mentioned. The jobs are available in Full Time basis. When it comes to Elexes Medical Consulting recruitment, fresher’s are mostly chosen for the department Engineer (Core, Non-IT). To learn more about the current jobs and other details, it is better to go through official site of Elexes Medical Consulting and Freshersworld. The Freshersworld is a leading employment portal that researches the official site of Elexes Medical Consulting and provides details about the current vacancies, the application process, selection process, test details, important dates and other information.

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