1232 Mdr Jobs - Page 7

Position: Promo Mats / Veeva Vault/ Regulatory / Medical Devices Exp: 2-6 years Location: Chennai Position Description : Hands on experience in Veeva Vault, Promo Mats, and other systems to review and verify regulatory documentation, minimizing manual effort. Ensure all regulatory claims, supporting evidence, and documentation are complete, accurate, and properly linked in digital systems. Identify and address gaps or inconsistencies in documentation or claims, flagging issues for resolution. Collaborate with cross-functional teams to improve data management processes and ensure compliance with EU MDR and global regulations.

Job Requirements Role/ Job Title: Lead-Cyber Defense Center Function/ Department: ISG Job Purpose The objective of the role is to manage & lead 24 x 7 Cyber Security Operations (Commercial SOC), Managed IT Infrastructure, Implement Standards, Policies & Procedures, Threat Hunting, VAPT, Incident Response & Resolution, Root Cause Analysis & Digital Forensic Investigation, Roles & Responsibilities Manage & lead 24 x 7 Cyber Security Operations (Commercial SOC), Managed IT Infrastructure, Implement Standards, Policies & Procedures, Threat Hunting, VAPT, Incident Response & Resolution, Root Cause Analysis & Digital Forensic Investigation. SIEM Implementation, onboarding new devices, fine tuning,...

Specialize in the treatment of respiratory diseases and critical care Help patients breathe easier with your expertise Eligibility : MBBS, MD, DM (Pulmonology) with at least 5 years of experience in respiratory care and critical care.

Client-Focused Project Execution: Lead packaging development projects based on customer specifications, regulatory requirements, and timelines. Serve as the primary technical interface between internal teams and client stakeholders. Translate customer needs into actionable packaging solutions and ensure timely delivery. Technical Leadership: Design, develop, and validate packaging systems Ensure packaging meets functional, regulatory, and sustainability standards. Oversee testing protocols, including transit, shelf-life, etc. Team & Process Management: Lead and mentor a team of packaging engineers and technicians. Coordinate cross-functional efforts across design, quality, procurement, and o...

Job Description This role involves the development and application of engineering practice and knowledge in designing, managing and improving the processes for Industrial operations, including procurement, supply chain and facilities engineering and maintenance of the facilities. Project and change management of industrial transformations are also included in this role. Job Description - Grade Specific Focus on Industrial Operations Engineering. Develops competency in own area of expertise. Shares expertise and provides guidance and support to others. Interprets clients needs. Completes own role independently or with minimum supervision. Identifies problems and relevant issues in straight fo...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Write Investigation Summaries based on technical product analysis information provided by the plant. A Good knowledge in Electrical and Electronics Domains: A good understanding of electrical and electronic systems, particularly as they relate to complex medical devices like ventilators. Knowledge of Biomedical Equipment: Familiarity with the functionality, design, and clinical application of biomedical devices, including troubleshooti...

Position Title: Senior Security Operations Engineer Reports To: Director of Security Operations Senior Security Operations Engineer is a technical subject matter expert responsible for executing key functions of CDK’s Security Monitoring and Response strategy with an automation first mindset. This individual plays a key technical role in our Security Operations organization and enables effective incident response via automated workflows and efficient threat detection content. Key Responsibilities : 1. Technical Leadership: Exemplify security principles and culture Develop, implement, and tune automation playbooks that enable incident response Self-starter who spots improvement opportunities ...

Job Title: Sales Executive – Lead Generation (Cybersecurity) Location: Work From Office (MOHALI) Department: Sales Employment Type: Full-Time About SafeAeon Inc. SafeAeon Inc. is a global cybersecurity service provider specializing in 24/7 Managed Security Operations, MDR, and compliance solutions. We partner with MSPs, MSSPs, and enterprises to strengthen their cybersecurity posture, reduce risks, and enhance operational visibility. We are expanding our sales team and seeking a dynamic Sales Executive (Lead Generation) to help us identify, engage, and connect with potential clients in the cybersecurity domain. Key Responsibilities: Conduct outbound lead generation through calls, emails, and...

Professional experience in regulated industry. Experience level 5 years . Regulatory background (preferably IVD/IVDR ; but MDR is acceptable) Must have experience with GSPR, SSPs, Technical Files, TFI, PER. Rework of Technical Files. Technical background in IVD and/or immunology

Company Description SafeAeon is a top-tier Cybersecurity-as-a-Service provider, offering 24x7 premium Managed Security Services with an AI-powered and human-driven SOC. The company leverages cutting-edge technology to provide cost-effective next-gen cybersecurity solutions. Specializing in SOC, MDR, EDR, DLP, Email Security, Penetration Testing, Digital Forensics, Incident Response, and Threat Intelligence, SafeAeon serves clients in over 20 countries. SafeAeon delivers comprehensive solutions to combat evolving cyber threats. Role Description This is a full-time, on-site role for a Social Media Marketing Specialist located in Mohali district. The Social Media Marketing Specialist will be re...

Summary The Senior Quality Complaints Investigator I is responsible for performing and aiding in complaints investigations as well as product performance, complaint reporting to regulatory agencies and trend analysis activities. Responsibilities Maintain complete and accurate complaint records. Evaluate the potential risks associated with customer complaints and prioritize investigations accordingly. Able to identify patterns to proactively address potential product issues. Conduct initial investigations to determine the nature and severity of complaints. Assists with drafting and filing adverse event reports with RA authorities Lead and oversee complex complaint investigations, including th...

We are seeking an Cybersecurity – India Sales to lead revenue growth across India. This role is responsible for building deep client relationships, expanding existing accounts, and driving new business across public sector, PSU, energy, infrastructure, and regulated industries. The ideal candidate will bring a sharp understanding of the cybersecurity landscape - particularly OT, SOC, IDAM, managed services, and threat intelligence - and the complex buying ecosystem in India. Preferred Qualifications Bachelor’s degree in Engineering, Computer Science, Business Management or equivalent OR Bachelor's Or Masters Degree in Cybersecurity Cybersecurity certifications (e.g., CISM, CISSP, CEH) and/or...

Job Title: Senior Labeling Specialist Trainer – Medical Devices Industry Location: Remote Job Type: Part-time Job Summary: We are seeking an experienced Labeling Specialist Trainer with over 10 years of expertise in medical device labeling, regulatory compliance, and documentation control . The trainer will be responsible for developing and delivering comprehensive training programs that enhance the understanding of global labeling standards, systems, and processes among regulatory, quality, and manufacturing teams. The ideal candidate will have a deep understanding of medical device labeling regulations (FDA, EU MDR, ISO 15223, ISO 20417, UDI requirements) and experience in label design too...

The Opportunity: The incumbent is responsible for selling to new channel partners/distributors and cross/up/repeat sales to existing channel partners/distributors. Maintain existing relationships with organizations distributing products, services and/or solutions. Deliver product demonstrations, sales bids and presentations to channel partners/distributors. Manage the relationship with the channel partners/distributors. What were looking for: Education: Science Graduates or Postgraduates / MBA are preferred. Experience: Minimum of 8+ years of IVD sales experience required How you will thrive and create an impact: Develops and executes territory plan to achieve revenue targets and control exp...

Summary: The Senior Quality Complaints Investigator I is responsible for performing and aiding in complaints investigations as well as product performance, complaint reporting to regulatory agencies and trend analysis activities. Responsibilities: Maintain complete and accurate complaint records. Evaluate the potential risks associated with customer complaints and prioritize investigations accordingly. Able to identify patterns to proactively address potential product issues. Conduct initial investigations to determine the nature and severity of complaints. Assists with drafting and filing adverse event reports with RA authorities Lead and oversee complex complaint investigations, including ...

Role Description Job Description: Associate III – Business Analysis (Regulatory Affairs – Life Sciences Publishing) Role Summary The Associate III – Business Analyst (Regulatory Affairs – Publishing) plays a crucial role in supporting regulatory operations within the life sciences industry. This role involves understanding stakeholder needs, gathering and analyzing requirements, and assisting in the creation and maintenance of regulatory submission documentation. The associate is also responsible for publishing regulatory submissions in compliance with global health authority standards and guidelines, under guidance from Senior BAs and Regulatory Leads. Key Responsibilities Business Analysis...

Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive t...

Acronis is revolutionizing cyber protection—providing natively integrated, all-in-one solutions that monitor, control, and protect the data that businesses and lives depend on. We are looking for a Junior/Mid MDR Analyst to join our mission to create a #CyberFit future and protect all data, applications and systems across any environment. The Junior/Mid MDR Analyst is responsible for investigating and triaging EDR/XDR incidents within the Acronis MDR service. This role focuses on accurate detection analysis, execution of predefined remediation steps, and clear customer communication, while contributing to continuous service improvement. The analyst will work closely with senior team members ...

Overview: The SOC Engineer L1/2 will be responsible for monitoring and analyzing security alerts to identify and respond to potential threats in real-time. Knowledge of correct teams for escalations. You will play a pivotal role in advising our clients on the optimization, and maintenance of SOC services Requirements: Must have 2-3+ years’ experience monitoring and analyzing security alerts to identify and respond to potential threats in real-time. Knowledge of correct teams for escalations Some expereince with Alert Management Triage and analyze alerts, prioritize high-severity threats, escalate when needed, and ensure timely resolution Must have Experience with MDR tools - Wirespeed ( MDR)...

Responsibilities: Develop & implement quality systems using ISO13485, Six Sigma Green Belt, ISO9001. Conduct audits, manage CAPAs, ensure FDA/QSR/MDR compliance. Work closely with R&D for (NPI) to ensure quality planning (DFMEA, PFMEA, Control Plan)

We are looking to add an experienced Clinical Writer to our team. The person in this position must be able to independently contribute to the development of initial and update(s) of CERs that support the applicable regulatory submission requirements for the medical device products. An experienced Clinical Analyst professional has relevant medical/life-science qualification and knowledge/direct clinical experience in the use of the device or device type in a clinical setting. The expected experience is 7 - 8 years with a minimum of 4-5 years of CER writing experience is essential. A minimum of 4-5 years of medical writing/reviewing experience is needed. The experience is expected to be curren...

Roles & Responsibilities Conduct post-market data analysis (complaints, adverse events, service reports, literature, vigilance data). Prepare and maintain PMS reports, PSURs, and trend analyses. Support risk management updates and product safety evaluations. Collaborate with cross-functional teams for CAPA and field actions. Ensure compliance with EU MDR, ISO 13485, and ISO 14971 requirements. Support audit and regulatory submission activities. Qualifications Bachelor’s degree in Engineering, Medical, Biomedical, or related field. 3–5 years’ experience in PMS, complaint handling, or post-market quality (medical device preferred). Strong knowledge of EU MDR, ISO 13485, and vigilance reporting...

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. Assess the regulatory impact of product and process changes and ensure proper documentation and notification. Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings. Review and approve produ...

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. Assess the regulatory impact of product and process changes and ensure proper documentation and notification. Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings. Review and approve produ...

Roles & Responsibilities Conduct post-market data analysis (complaints, adverse events, service reports, literature, vigilance data). Prepare and maintain PMS reports, PSURs, and trend analyses. Support risk management updates and product safety evaluations. Collaborate with cross-functional teams for CAPA and field actions. Ensure compliance with EU MDR, ISO 13485, and ISO 14971 requirements. Support audit and regulatory submission activities. Qualifications Bachelor’s degree in Engineering, Medical, Biomedical, or related field. 3–5 years’ experience in PMS, complaint handling, or post-market quality (medical device preferred). Strong knowledge of EU MDR, ISO 13485, and vigilance reporting...