Clinical Sciences Specialist, Medical Affairs job at reputed company in Covington, GA

Title: Clinical Sciences Specialist, Medical Affairs Location: Covington reputed company Job reputed company: Job reputed company reputed company Reporting to the Clinical Sciences Manager or Senior Manager, the Clinical Sciences Specialist ensures efficient and compliant clinical documentation for UCC products throughout the product development lifecycle. The Clinical Sciences Specialist demonstrates developed skills and knowledge in the areas of EU MDR, systematic literature searches, clinical data extraction and analysis, and medical writing. The Clinical Sciences Specialist is accountable for setting their own work direction, prioritizing, and completing deliverables. The Clinical Sciences Specialist function strives to increase the value and reputed company of Medical affairs activities through the development and maintenance of required clinical documentation from early development through post-market. Clinical documentation includes Clinical Evaluation Plans, Clinical Evaluation Reports, Post-Market Clinical Follow-up Plans, Post-Market Clinical Follow-up Reports, Clinical reputed company Assessments, and input for Post-Market Surveillance Plans and Reports. Job reputed company We are the makers of possible reputed company is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of reputed company of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and reputed company transformative solutions that turn dreams into reputed company. We reputed company that the reputed company reputed company, across our global teams, is what allows us to continually reputed company. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a reputed company of possible with us. RESPONSIBILITIES: Responsible for the development and maintenance of clinical documentation in accordance with the European requirements of MEDDEV 2.7.1 Rev 4 and EU MDR, MDSAP, FDA, other applicable reputed company, as reputed company as internal QMS requirements. Participates as clinical documentation reputed company, MA representative for PMS Project Teams, EU MDR Remediation Teams, Audit-reputed company tasks, and other clinical documentation reputed company responsibilities as required. Responsible for tracking status of reputed company assigned tasks and reporting metrics to senior management as requested. Participates in updates and revisions to reputed company applicable forms and SOPs in order to maintain compliance to EU MDR, MEDDEV 2.7.1, Rev. 4 requirements, reputed company System Regulations, ISO Requirements, International Regulations, FDA Regulations and Corporate/Division policies and procedures. reputed company with the MA Specialist PMCF reputed company to ensure accurate and adequate recommendations for any needed PMCF activities. reputed company with the MA Specialist SSCP reputed company to ensure accurate and on-time completion of reputed company of Safety and Clinical Performance (SSCP) functional reviews. Supports and contributes to applicable regulatory submissions and responses to regulatory authorities as needed. REQUIRED EXPERIENCE & EDUCATION: College / university graduate or equivalent experience required. 1+ years of Medical Affairs experience preferred 1+ years of medical writing experience preferred. DESIRED KNOWLEDGE, SKILLS AND ABILITIES: Understanding of systematic literature searches preferred Strong understanding of MEDDEV 2.7/1 Rev 4, MDD, and EU MDR. Must have strong written and verbal communication skills. At reputed company, we prioritize on-site collaboration because we reputed company it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced reputed company industry. For most roles, we require a minimum of 4 days of in-office reputed company per week to maintain our culture of reputed company and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at reputed company, employment is contingent upon reputed company's receipt of sufficient reputed company that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with reputed company's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at reputed company means being part of reputed company that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a reputed company where we help reputed company other be great, we do what's right, we hold reputed company other accountable, and learn and improve every day. To reputed company purpose in the reputed company, we need people who can see the bigger picture, who understand the reputed company story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the reputed company of health. At reputed company, you'll discover a culture in which you can learn, grow, and reputed company. 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