Staff Clinical Evaluation Specialist (Remote)

Work Flexibility: Remote or Hybrid or Onsite

Stryker is hiring a Staff Clinical Evaluation Specialist this position is Remote supporting our Joint Replacement Division. Preference will be given to candidates in the Eastern and Central locations of the United States.

In your role as a Staff Clinical Evaluation Specialist on the Clinical Affairs team you will lead the process of planning writing and updating Clinical Evaluation documentation (e.g. CERs CEPs SSCPs PMCFPs PMCFRs) to bring State of the Art medical devices to market. You will act as the subject matter expert that drives Clinical Evidence generation. You will conduct thorough research on the subject device perform systematic reviews of published literature extract data interpret trends and communicate scientific findings to support regulatory body submissions for diverse geographies. You will apply your project management skills to compile the body of Clinical Evidence on which you in collaboration with other stakeholders will reach a scientific conclusion on the safety and performance of our products throughout its entire lifecycle. Your valuable work will help deliver industryleading Joint Replacement products to the customer and rebuild lives of patients across the globe.

What you will do

• Prepares clinical documentation to validate device safety and performance for regulatory body submissions and perform periodic updates to maintain compliance (e.g. CERs CEPs PMCFRs PMCFPs SSCPs).
• Supports the needs of other business units (e.g. R&D Marketing Clinical Research) regarding communication of clinical data in the form of peerreviewed publications white papers 1pagers clinical summaries posters and slide decks/presentations.
• Designs compliant and sustainable literature search strategies performs systematic reviews to capture and summarize published clinical data and analyzes current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques.
• Acts as the dedicated Clinical Evaluation Project Manager driving the establishment of a coherent Clinical Evidence strategy throughout the new product development cycle and fosters alignment with adjacent processes (marketing strategy and claims regulatory strategy clinical research strategy preclinical testing strategy).
• Identifies appraises and analyzes relevant clinical postmarket surveillance marketing and preclinical testing data to create comprehensive scientific reviews which may include indepth quantitative analyses qualitative analyses and risk management crosschecks.
• Forms a conclusion on the overall benefitrisk profile of the subject device in collaboration with a Medical Expert and other stakeholders based on uptodate US European and Australian regulatory requirements.
• Identifies unanswered questions and residual risks in the Clinical Evidence and designs Post Market Clinical Follow Up activities in collaboration with Clinical Research to address these questions.

What you need

• A minimum of a Bachelors Degree (B.S. or B.A.) in Life Sciences Engineering or similar concentration required.
• A minimum of 4 years of experience in an FDA or highly regulated industry required; preferably with medical devices.
• A minimum of 2 years in a Regulatory Affairs role required.
• Experience in scientific writing performing systematic reviews analyzing published literature and statistical methods (may be in the form of peerreviewed publications).

Preferred

• Strong interest in medical science clinical research and scientific communication.
• Demonstrated project management and organizational skills.
• Knowledge of FDA / MDR regulations for medical devices.
• Independent problem solver and ability to apply creative solutions

$105100.00 $172300.00 USD Annual salary plus bonus eligible benefits. Actual minimum and maximum may vary based on pay is based on skills experience and other relevant factors

Travel Percentage: None

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 contractors legal duty to furnish information.