• Job Description

  Req#: R524504
  Work Flexibility: Hybrid

  Stryker Emergency Care is seeking a Post Market Clinical Affairs Specialist to be based hybrid in Redmond, WA.

  Who we want

  • Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

  What you will do

  As the Post Market Clinical Affairs Specialist, you will be responsible for clinical assessments within the post-market surveillance (PMS) space . This role is responsible for assessing compliance with internal and external safety and performance requirements for medical devices, by reviewing, analyzing and concluding on clinical evidence.

  • Responsible for on-time submission of vigilance reports and medical risk assessments.

  • Maintains systems to track, manage, and report product complaints and adverse events.

  • Operational and regulatory responsibility of individual clinical assessments, defending them in audit situations.

  • Prepare clinical assessment documentation to validate device safety and performance for regulatory body submissions and perform periodic updates to maintain compliance (e.g., MDRs and MIRs ).

  • Provides inputs for non-conformances, complaint investigations, field action/recall activities, and audit responses .

  • Participates in various reviews of laws, guidance, and standards of complaint handling activities .

  • Under supervision, plans, conducts, and supervises assignments and projects .

  • Assists in the development and maintenance of regulatory procedures and SOPs .

  • Assists in the preparation for meetings with regulatory agencies and other stakeholders .

  • Demonstrated skills in critical care monitoring techniques and ECG rhythm interpretation .

  • Ability to compose and edit technical and clinical documents for regulatory submissions .

  • Ability to collaborate with a variety of functional areas, including marketing and engineering .

  • May pr ovide a conclusion on the overall benefit-risk profile of the subject device, in collaboration with a Medical Expert and other stakeholders, based on up-to-date US, European, and other country’s regulatory requirements.

  What you need

  • Bachelor’s degree required, preferably in Nursing or related area.

  • Minimum 0-2 years critical care and/or emergency experience.

  • Post market surveillance experience preferred.

  • AHA ACLS current or prior provider status required and recommended to be maintained.

  • Current RN, EMT, or equivalent preferred.

  • Demonstrated skills in critical care monitoring techniques and ECG rhythm interpretation.

  • Demonstrated ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.

  $64,400.00 - $89,700.00 USD salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

  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.

• About the company

  Stryker Corporation is an American multinational medical technologies firm based in Kalamazoo, Michigan.

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