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Staff Specialist, Adverse Event Reporting Divisional Process Owner

1 month ago

Portage, United States Stryker Full time

Work Flexibility: Hybrid

Stryker is hiring a Staff Specialist, Adverse Event Reporting Divisional Process Owner (Hybrid) to be the vanguard of excellence within our esteemed Instruments Division, who will be the guardian of regulatory adherence, you'll lead the charge in fortifying our adverse event reporting processes to meet and exceed the rigorous standards set by governing bodies. In this hybrid role, you'll be more than just a compliance champion - you'll be a catalyst for innovation and efficiency. With your finger firmly on the pulse of regulatory updates, you'll spearhead transformative changes, ensuring our reporting processes remain at the peak of effectiveness.

Who we want:

  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.
What you will do:
  • Ensure compliance with regulatory requirements for adverse event reporting (AER), including updates and changes.
  • Support audits related to AER, MDR, and MIR records.
  • Assist in quarterly VMSR submissions and NC/CAPA activities.
  • Participate in GPO calls and MIR Forum sub-team meetings.
  • Lead Monthly Late AER Board documentation and present metrics at QRB meetings.
  • Develop procedures for AER, provide training, and conduct risk assessments.
  • Act as primary liaison with regulatory agencies for AER.
  • Implement quality assurance measures for AER reports.
  • Continuously improve AER process and regulatory compliance.
  • Manage annual licenses, registrations, and listings.
  • Ensure regulatory compliance in advertising, post-market requirements, and product safety reporting.
  • Handle regulatory strategy, recalls, and communication with stakeholders.
  • Provide regulatory input throughout the product lifecycle.
  • Identify and address regulatory obstacles and market access requirements.
  • Evaluate products for regulatory classification and jurisdiction.
  • Determine submission requirements and compliance activities.
  • Provide regulatory guidance for product development.
  • Negotiate with regulatory authorities.
  • Develop and implement new regulatory procedures and SOPs.
  • Train stakeholders on regulatory requirements and assist in SOP development.
What you will need
  • Bachelor's degree required, preferred in a Science or Engineering discipline.
  • Minimum of 5 years' experience in post market surveillance and/or Adverse Event Reporting (AER).
  • Demonstrated adept project management skills, focusing on technical and scientific regulatory tasks.
  • Proficient in regulatory pathways, risk-benefit analysis, and effective communication both internally and externally.
  • Executes tasks from submission to post-marketing surveillance, ensuring compliance and documentation.
  • Works independently under general supervision, overseeing assignments, reviewing progress, and suggesting procedural changes.
  • Exercises autonomy in decision-making, while seeking diverse perspectives and embracing feedback for continuous improvement.
  • Capable of directing specialist teams and navigating organizational dynamics to achieve desired outcomes.
  • Proactively seeks challenging opportunities for personal and professional growth.


Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

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