Stryker

Staff Specialist, Adverse Event Reporting

Stryker

Dallas, TX, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

At Stryker, we are dedicated to providing innovative medical devices and solutions to improve patient outcomes. We are currently seeking a highly skilled and motivated Staff Specialist, Adverse Event Reporting to join our team. In this role, you will play a critical role in ensuring the safety and effectiveness of our products through timely and accurate reporting of adverse events. As a member of our team, you will have the opportunity to make a meaningful impact on the lives of patients and contribute to the advancement of medical technology. We are looking for individuals who are detail-oriented, have strong communication skills, and possess a deep understanding of medical device regulations and adverse event reporting requirements. If you are passionate about patient safety and have the qualifications we are looking for, we encourage you to apply for this exciting opportunity.

  1. Monitor and track adverse event reports received from healthcare professionals, patients, and other sources according to established procedures and timelines.
  2. Conduct thorough investigations and evaluations of adverse events, including gathering and analyzing all relevant information and documentation.
  3. Collaborate with cross-functional teams to ensure timely and accurate reporting of adverse events to regulatory agencies and internal stakeholders.
  4. Maintain a comprehensive understanding of medical device regulations and adverse event reporting requirements, and ensure compliance with all applicable laws and standards.
  5. Develop and maintain standard operating procedures and training materials related to adverse event reporting.
  6. Identify and escalate potential safety issues or trends to management and other relevant parties.
  7. Communicate with healthcare professionals, patients, and other stakeholders to obtain additional information and/or provide updates on adverse event reports.
  8. Participate in internal and external audits and inspections related to adverse event reporting.
  9. Serve as a subject matter expert on adverse event reporting, providing guidance and support to other team members as needed.
  10. Stay current on industry trends and best practices related to adverse event reporting and share knowledge and insights with the team.
  11. Ensure confidentiality and accuracy of all adverse event data and documentation.
  12. Adhere to all company policies and procedures, including those related to safety, quality, and compliance.
  13. Collaborate with other departments, such as Regulatory Affairs and Quality Assurance, to ensure alignment and consistency in adverse event reporting processes and procedures.
  14. Participate in continuous improvement initiatives to enhance the efficiency and effectiveness of adverse event reporting processes.
  15. Represent the company in a professional manner, both internally and externally, and uphold the company's values and reputation.
Where is this job?
This job is located at Dallas, TX, USA
Job Qualifications
  • Strong Knowledge Of Medical Device Regulations: A Staff Specialist, Adverse Event Reporting At Stryker Should Have A Thorough Understanding Of The Medical Device Industry And The Regulations That Govern It, Such As Fda Regulations And Iso Standards.

  • Experience In Adverse Event Reporting: The Ideal Candidate Should Have At Least 3-5 Years Of Experience In Adverse Event Reporting For Medical Devices. This Includes Knowledge Of Adverse Event Classification, Reporting Requirements, And Submission Processes.

  • Attention To Detail: Adverse Event Reporting Is A Critical Aspect Of The Medical Device Industry, And Accuracy Is Crucial. The Candidate Should Have Excellent Attention To Detail To Ensure All Adverse Events Are Properly Documented And Reported.

  • Analytical Skills: As A Staff Specialist, Adverse Event Reporting, The Candidate Should Be Able To Analyze Complex Data And Identify Trends And Patterns In Adverse Events. This Will Help In Identifying Potential Safety Issues And Implementing Corrective Actions.

  • Communication And Collaboration: Adverse Event Reporting Involves Working With Various Teams, Including Product Development, Quality Assurance, And Regulatory Affairs. The Candidate Should Have Excellent Communication Skills And The Ability To Collaborate Effectively With Cross-Functional Teams.

Required Skills
  • Risk Management

  • Quality Assurance

  • Project Management

  • Data Analysis

  • Communication

  • Incident investigation

  • Attention to detail

  • Critical Thinking

  • Medical Terminology

  • Regulatory compliance

  • Team collaboration

  • Problem-Solving

Soft Skills
  • Communication

  • Conflict Resolution

  • Customer Service

  • Leadership

  • Time management

  • creativity

  • Attention to detail

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Staff Specialist, Adverse Event Reporting in Dallas, TX, USA is $61,000 to $130,000 per year. This range can vary depending on factors such as the size and industry of the company, the candidate's experience and qualifications, and the specific responsibilities and duties of the role. Some companies may also offer additional benefits and bonuses as part of their compensation package. It is important to research and negotiate a fair salary based on your individual skills and experience when considering a job offer.

Additional Information
Stryker is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedMay 16th, 2024
Apply BeforeMay 22nd, 2025
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About Stryker

Stryker Corp. is engaged in providing medical technology products and services. It operates through the following segments: Orthopaedics, MedSurg and Neurotechnology and Spine. The Orthopaedics segment provides reconstructive and trauma implant systems. The Medsurg segment deals with surgical instruments and equipment, endoscopy, patient handling, and reprocessed medical devices. The Neurotechnology and Spine segment pertains to spinal implants and neurovascular products.

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