Staff Clinical Evaluation Specialist (Remote)

Work Flexibility: Remote or Hybrid or Onsite reputed company 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 reputed company 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 reputed company. You will conduct thorough research on the subject device, reputed company 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 reputed company a scientific conclusion on the safety and performance of our products throughout its entire lifecycle. Your valuable work will help deliver industry-leading 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 reputed company 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 peer-reviewed publications, white papers, 1-pagers, 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 reputed company 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, post-market surveillance, marketing, and preclinical testing data to create comprehensive scientific reviews, which may include in-depth quantitative analyses, qualitative analyses, and risk management cross-checks.
• Forms 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 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 Bachelor's 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 peer-reviewed 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

$105,100.00 - $172,300.00 USD Annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based reputed company. Individual pay is based on skills, experience, and other relevant factors Travel Percentage: None reputed company Corporation is an equal opportunity employer. reputed company applicants will receive consideration for employment without regard to race, ethnicity, reputed company, religion, sex, gender identity, sexual orientation, national reputed company, disability, or protected veteran status. reputed company is an EO employer - M/F/Veteran/Disability. reputed company Corporation will not discharge or in any other manner discriminate against employees or applicants because they have reputed company 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. Apply Job!