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., CE - Rs, CE - Ps, SSCPs, PMCF - Ps, PMCF - Rs) 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, inter... more details
Work Flexibility: Hybrid
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com
We are currently seeking a Staff Clinical Evaluation Specialist join the Clinical Affairs, Joint Replacement Division, with the flexibility of hybrid work arrangements.
Who We Want
- Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
- Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
- Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
What you will do
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 industry-leading Joint Replacement products to the customer and rebuild lives of patients across the globe.
- 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 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 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, 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.
- Strong interest in medical science, clinical research, and scientific communication.
- Experience in scientific writing, performing systematic reviews, analyzing published literature, and statistical methods (may be in the form of peer-reviewed publications).
- Demonstrated project management and organizational skills.
- Knowledge of FDA / MDR regulations for medical devices preferred.
- Independent problem solver and ability to apply creative solutions.
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 contractor’s legal duty to furnish information.
