Job Description
Careers that Change Lives
Review, evaluate, classify and perform follow up activities on all product complaints relative to the identity, quality, reliability, safety and effectiveness of medical devices. Evaluates for reporting criteria to Government...
...SBT is looking for a Marketing Development Representative (MDR) Team Lead to join our dynamic Marketing team
This pivotal role supports our Director of Demand Gen, Marketing, by spearheading our outbound marketing initiatives
In this player-coach role, you will refine...
Careers that Change Lives
Review, evaluate, classify and perform follow up activities on all product complaints relative to the identity, quality, reliability, safety and effectiveness of medical devices. Evaluates for reporting criteria to Government Agencies to determine...
~ Intake of source documents, promote them to complaints, follow-up with Reps, determine Reportability, file Regulatory Reports and write Investigation Summaries based on technical product analysis information provided by the plant.
Must Have
Job Responsibilities
...
Ankura is a team of excellence founded on innovation and growth.
Join Ankura's rapidly growing Cybersecurity practice and become a key player in protecting our clients from the ever-evolving threat landscape.
Practice Overview
Our diverse team is comprised of seasoned...
...Alto CorteX, SentinelOne, TrendMicro, Elastic, CrowdStrike
Technical Experience:
1. Strong knowledge of Antivirus/EDR/HIPS/XDR/MDR etc.
2. Strong knowledge of security principles, standards, and techniques.
Professional Attributes:
1. Should be open to...
...element analysis (FEA) techniques and software (e.g., ANSYS, Abaqus).
~ Experience with design for manufacturing (DFM) principles and practices.
~ Familiarity with ISO 13485 quality management system requirements and medical device regulations (e.g., FDA QSR, EU MDR)....
...issues and drawings/documents in a timely and efficient manner.
Roles and Responsibilities
Maintain a Master Document Register (MDR) consisting of drawings, specifications, procedures and plans.
Examine documents such as blueprints, drawings, change orders, and specifications...
...various regulatory documents related to clinical.
Prepare and update procedures related to Clinical Trial Department accordance with MDR, 21CFR and others. Responsible for quality and compliance and ensure that activities are performed in accordance with policies,...
...experience in managing SOC teams within a Managed Security Operations function, particularly with a focus on Managed Detection and Response (MDR) and Managed SIEM. The role involves a hands-on approach to daily SOC activities, strategic leadership in process enrichment, and...
...Job Description (Posting).
SOC JD - E3.1 - 4+ years of experience in a multi tiered SOC/IR/MDR teamShould have worked as a SOC leadExperienced with Technologies such as EDR, SIEM, SOAR, FWDeep understanding of attack trends and threat detection servicesFamiliarity with...
...security concerns in cloud environments Implement security measures and tune existing tools to further enforce zero trust monitorning for MDR model Delivery Design and implement innovative approaches to endpoint protection, malware detection & mitigation, and auditing....
...engineering, applied sciences or a related discipline
✓
3+ years of professional experience in medical deviceregulatory affairs EU MDR, US FDA 510(k) and closely working R&D, Quality organizations
✓
Knowledge and application of medical device QMS is required
✓...
...working knowledge of Standards like IEC62304/82304/60601
Excellent working knowledge of medical device regulations (21CFR), FDA Law, MDD, MDR, other global laws and regulations.
Experience in supporting international registrations and clinical investigations(as a plus)...
...Software), risk management, reliability engineering, process validation and Quality systems Basic understanding of and adherence to FDA,MDD/MDR , ISO and IEC design control procedures, regulations and standards. Self-motivated with good interpersonal skills. Ability to follow...
Rs 7 - 8 lakhs p.a.
...Location: Daman
Experience: 8to 12 Years
Industries: Pharma
Responsibilities:
Maintaining compliance with ISO 13485, MDD, and MDR requirements.
Preparing technical and device master files
Preparing and compiling documents for registration to various countries...
...knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA 21 CFR Part 820, ISO 13485, IVDR and MDR)
~ Must have knowledge and experience in working with ISO 14971 and IEC 62304
~ Knowledge & experience on Agile/ Scrum SW development...
...Instrument Hookups
Electrical Wiring Diagram
Logic Diagram
Cause & Effect
Control Narratives
Documentation Index for MDR/SDRL/VDRL.
Quality Plan /ITP
Installation, Operation & Maintenance Manual
Detailed Engineering Calculations
Participating &...
...leader by Gartner and IDC, and for having a great company culture by Comparably.
TraceLink seeks Market Development Representatives (MDR) to join our team onsite in Pune. As an MDR at TraceLink your role is to qualify and mature TraceLink’s inbound leads globally.
As...
...Undertake other tasks as required by the Lead Document Controller / Manager - Document Control
Maintain a Master Document Register (MDR) consisting of drawings, specifications, procedures and plans
Setup and maintain data in the Electronic Document Management System &...
...coordinate for query resolution, and ensure that the registration formalities are completed.
Perform gap assessment of EU MDD to EU MDR and remediation activities. Perform Technical file compilation.
Maintaining submission tracker.
Responsible for US FDA 510K technical...
...3485:2016 and relevant quality requirements (e.g., 21 CFR 820, MDSAP).
Strong understanding of medical device regulations (e.g., EU MDR 2017/745, US FDA, etc.,)
Experience with developing and maintaining quality system documentation.
Experience with conducting audits...
...models and ensure clash-free with other disciplines
~ Ensure design deliverables are completed and issued per project specifications, MDR, and project Level 2 & 3 procedures, and within agreed schedules
~ Apply knowledge and/or skills to complete а variety of day-to-day...
...in complaint handling or customer quality.
~ Understanding of Post Market Surveillance requirement of Medical Devices under FDA & EU MDR regulations
~ Understanding on Medical Device Risk Management
~ Hands-on Experience on Complaint handling and Product investigations...
...enthusiastic and strategic thinker with a drive for quality.
~ Excellent negotiating skills
~ Familiarity with:
~ EN ISO 13485:2016
~ MDR (EU)2017/745
~ MDD (93/42/EEC)
~ MDSAP
~ IEC 62304 Medical Device Software Life Cycle Processes
~ IEC 14971 Risk Management to...
...2016, 21 CFR 820, and risk management principles outlined in ISO 14971.
Familiarity with medical device regulations (21 CFR, MDD/EU MDR, MDSAP) and relevant global quality standards.
Proficiency in LEAN concepts and methodologies for continuous improvement.
Strong...
...apprised of all activities, progress and concerns
Participate in design reviews and audits
Capture lessons learned and enter into MDR's Lessons Learned system
Capture Knowledge Objects and enter into MDR's K.now system
Develop basic understanding of MDR's...
...Management Process implementation & monitoring
o Security Event & Incident Management technology implementation & monitoring
o XDR/MDR Implementation & monitoring
o IAM/MFA/Identity/Zero-Trust/Conditional access implementation & monitoring
o Security Awareness/...
...Sales Executive
Company— Aujas-
Experience: 3-5 yrs
Location: Bangalore / Mumbai
Budget – 10-12 LPA (70/30 Ratio)
Skill- MDR Services- SOC, SIEM ; (Security Verification Services –SAST/DAST/VAPT/
US Night Shift roles EST Timings (Hybrid model)
Notice...
...in Medical Device
Testing Method and Design Control
Cross Functional Collaboration
DHF Remediation and Sustaining Process.
MDR Remediation Activities.
Worked with Cross Function Team
Experience required – 12 – 17 Years
Travel – 10%
Requisition ID:...