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Mdr/Vigilance Specialist Ii

4-8 years
Not Disclosed
10 Aug. 6, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Begin Your Career in Innovation and Healthcare Advocacy at Medtronic

At Medtronic, embark on a life-long journey of exploration and innovation while championing healthcare access and equity for all. Lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life: Careers that Change Lives

Primary Responsibilities:

  • Complaint Handling: Review, evaluate, classify, and follow up on all product complaints related to the identity, quality, reliability, safety, and effectiveness of medical devices. Determine if events suggest that a device may have caused or contributed to death or serious injury and report to government agencies if necessary.
  • Technical Analysis: Write investigation summaries based on technical product analysis information provided by the plant.
  • Database Management: Evaluate incoming complaint information and maintain records in the electronic database. Perform follow-up activities to obtain additional information, analyze and trend data on complaints, and ensure accurate complaint categorization for trend accuracy.
  • Compliance: Maintain record documentation in a state of audit readiness per internal policies. Liaise with groups performing additional investigations and preparing written records of these investigations.
  • Interdepartmental Interaction: Collaborate with Technical Service, Manufacturing, R&D, and Quality Assurance during the complaint processing.
  • Regulatory Adherence: Provide technical expertise to handle complaints in compliance with FDA and international reporting regulations. Review and interpret risk management documentation related to complaint events.
  • External Interaction: Communicate with customers, vendors, healthcare professionals, and other external groups.

Minimum Qualifications:

  • Bachelor’s degree; Engineering or Science degrees preferred (e.g., Software, Electrical, Mechanical, Biomedical Engineering).
  • 4 to 8 years of quality assurance or regulatory experience in the medical or pharmaceutical industry.
  • Proficiency in Word, Excel, Access, PowerPoint, and database trending analysis.
  • Strong typing skills and ability to write business documents with minimal supervision.
  • Strong verbal and written communication skills and ability to work in a team-oriented environment.
  • Ability to multitask and understand the functionality/intended use of complex medical devices.

Preferred Qualifications:

  • Knowledge of medical devices, their development, and quality control.
  • Familiarity with FDA, MEDDEV, and Canadian regulations.
  • Experience in technical writing.

Physical Job Requirements

The statements above describe the general nature and level of work performed by employees assigned to this position. This is not an exhaustive list of all required responsibilities and skills.

Benefits & Compensation

Medtronic offers a competitive salary and flexible benefits package, reflecting our commitment to our employees. We recognize their contributions and share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology, boldly addressing the most challenging health problems by finding innovative solutions. Our mission—to alleviate pain, restore health, and extend life—unites a global team of over 90,000 passionate individuals. As engineers at heart, we turn ambitious ideas into real solutions for real people, from the R&D lab to the factory floor to the conference room. With diverse perspectives and a fearless approach, we engineer the extraordinary.

Learn more about our business, mission, and commitment to diversity here.

Medtronic is an equal opportunity employer committed to fostering an inclusive and diverse workplace.