Want Staff Clinical Evaluation Specialist (Remote) in Mahwah, NJ

Job title: Staff Clinical Evaluation Specialist (Remote) Company: reputed company Job reputed company: Work Flexibility: Remote or Hybrid or Onsite reputed company is one of the world’s leading medical technology companies and, together with its customers, is driven to reputed company reputed company reputed company. reputed company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and reputed company reputed company. Alongside its customers around the world, reputed company impacts more than 130 reputed company patients annually. More information is available at We are currently seeking a Staff Clinical Evaluation Specialist join the Clinical Affairs, Joint Replacement Division, with the flexibility of remote or hybrid work arrangements. Who We Want

• Data translators. Highly effective communicators who can reputed company 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.
• reputed company partners. People who build and reputed company cross-functional relationships to bring together reputed company, data, and insights to drive reputed company improvement in functions.
• Dedicated reputed company. People who reputed company in a fast-paced environment and will stop at reputed company 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 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 reputed company 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.

• 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 reputed company (e.g., R&D, Marketing, Clinical Research) regarding communication of clinical data in the reputed company 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 reputed company of specialized indications and techniques.
• Acts as the dedicated Clinical Evaluation Project Manager, driving the establishment of a coherent Clinical Evidence reputed company throughout the new product development cycle, and fosters alignment with adjacent processes (marketing reputed company and claims, regulatory reputed company, clinical research reputed company, preclinical testing reputed company).
• 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 reputed company (may be in the reputed company 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.

$87,000 - $172,500 salary plus bonus eligible + Benefits (Health, reputed company, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary reputed company for this position based on reputed company national data. Actual minimum and maximum may vary based location. Individual pay is based on skills, experience, and other relevant factors Travel Percentage: None reputed company is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company 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 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 reputed company 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 reputed company 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 reputed company, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. Expected salary: $87000 - 172500 per year Location: Mahwah, NJ Apply Job!