Stryker

Staff Specialist, Adverse Event Reporting

Stryker

Grand Rapids, MI, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Are you passionate about patient safety and data analysis? Do you have experience in quality assurance and regulatory compliance? Are you looking for an opportunity to make a meaningful impact in the medical device industry? If so, Stryker is seeking a highly qualified and motivated individual to join our team as a Staff Specialist for Adverse Event Reporting.As a global leader in medical technology, Stryker is committed to ensuring the safety and efficacy of our products. The Staff Specialist for Adverse Event Reporting will play a crucial role in this mission by overseeing the timely and accurate reporting of adverse events to regulatory agencies around the world. This individual will also be responsible for analyzing data to identify trends and potential areas for improvement in our products and processes.We are seeking applicants who possess a strong understanding of quality management systems and regulatory requirements, as well as excellent communication and data analysis skills. A Bachelor's degree in a relevant field and at least 3 years of experience in a similar role are required. Join us at Stryker and be a part of a dynamic team dedicated to making healthcare better.

  1. Oversee the timely and accurate reporting of adverse events to regulatory agencies around the world.
  2. Analyze data to identify trends and potential areas for improvement in our products and processes.
  3. Ensure compliance with all quality management systems and regulatory requirements.
  4. Communicate with regulatory agencies and internal teams to provide updates and respond to inquiries regarding adverse events.
  5. Develop and maintain standard operating procedures for adverse event reporting and data analysis.
  6. Train and educate employees on proper adverse event reporting procedures.
  7. Collaborate with cross-functional teams to identify and implement improvements in product safety and quality.
  8. Monitor and track adverse event reports and follow up on any necessary actions.
  9. Stay up-to-date on industry regulations and best practices related to adverse event reporting.
  10. Participate in audits and inspections related to adverse event reporting.
  11. Prepare and present reports and presentations on adverse event data and trends.
  12. Provide support and guidance to other team members as needed.
  13. Maintain confidentiality and adhere to ethical standards in all aspects of the role.
  14. Continuously strive for excellence and seek out opportunities for process improvement.
  15. Represent Stryker and promote our commitment to patient safety and quality in all interactions with external stakeholders.
Where is this job?
This job is located at Grand Rapids, MI, USA
Job Qualifications
  • Experience In Adverse Event Reporting: The Ideal Candidate Should Have A Minimum Of 3-5 Years Of Experience In Adverse Event Reporting, Preferably In The Medical Device Industry.

  • Knowledge Of Regulatory Requirements: The Candidate Should Have A Strong Understanding Of Global Regulatory Requirements For Adverse Event Reporting, Including Fda Regulations, Eu Regulations, And Other Relevant Guidelines.

  • Attention To Detail: As Adverse Event Reporting Involves Collecting And Analyzing Large Amounts Of Data, The Candidate Should Possess Excellent Attention To Detail To Ensure Accuracy And Completeness Of Reports.

  • Strong Communication Skills: The Candidate Should Have Excellent Written And Verbal Communication Skills To Effectively Communicate With Internal And External Stakeholders, Including Healthcare Professionals And Regulatory Authorities.

  • Ability To Work Independently And In A Team: The Candidate Should Be Able To Work Independently And Manage Their Workload, While Also Collaborating With Cross-Functional Teams To Ensure Timely And Accurate Adverse Event Reporting.

Required Skills
  • Risk Management

  • Communication Skills

  • Data Analysis

  • Time Management

  • Incident investigation

  • Attention to detail

  • Quality Control

  • Critical Thinking

  • Regulatory compliance

  • Problem-Solving

  • Medical coding

  • team

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Teamwork

  • Adaptability

  • Problem-Solving

  • Resilience

Compensation

According to JobzMall, the average salary range for a Staff Specialist, Adverse Event Reporting in Grand Rapids, MI, USA is between $67,000 and $90,000 per year. This range can vary depending on the specific company, years of experience, and other factors such as education and certifications.

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 BeforeJune 9th, 2026
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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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