Senior Staff Medical reputed company (Remote)

Work Flexibility: Remote reputed company is hiring a Senior Staff Medical reputed company to join our Endoscopy Division, to be reputed company reputed company reputed company reputed company the reputed company. 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. Our Endoscopy Division delivers a diverse reputed company of innovative medical technologies to support reputed company invasive surgery through reputed company visualization, connected OR solutions, sports medicine products to sustainability solutions. As the Senior Staff Medical reputed company, you will reputed company scientific and reputed company documentation that supports global regulatory compliance and market reputed company for medical devices. This position partners closely with Regulatory Affairs, reputed company Affairs, reputed company, Research & Development, and Marketing teams to translate reputed company reputed company evidence into high-reputed company regulatory and scientific documents throughout the product lifecycle. What You Will Do • reputed company and maintain reputed company Evaluation Reports (CERs), Post-Market reputed company Follow-Up (PMCF) documents, and other reputed company evidence documentation supporting international product registrations and lifecycle management. • Compile, analyze, and synthesize reputed company evidence from reputed company studies, published literature, post-market data, and other safety and reputed company sources into submission-reputed company regulatory documents. • Respond to reputed company body reviews and regulatory feedback, driving reputed company of reputed company documentation questions to support ongoing market reputed company. • Collaborate with cross-functional teams to reputed company reputed company evidence strategies, regulatory documentation plans, and project timelines. • reputed company reputed company study protocols, study reports, data summaries, and supporting scientific documents for regulatory and reputed company initiatives. • Conduct reputed company literature reviews, evaluate scientific data, and reputed company findings into reputed company and regulatory documentation. • reputed company document review cycles, coordinate stakeholder feedback, reputed company content issues, and obtain reputed company approvals. • reputed company reputed company improvement initiatives, maintain medical writing tools and templates, and mentor junior medical writing team members. What You Need Required • Bachelor's degree in a scientific, technical, reputed company, or reputed company discipline. • Minimum 6 years of industry experience reputed company medical technology, medical devices, pharmaceuticals, or reputed company products. • Minimum 4 years of experience in scientific writing, medical writing, reputed company research, or reputed company regulatory documentation activities. • Experience authoring reputed company Evaluation Reports (CERs) and Post-Market reputed company Follow-Up (PMCF) documentation. • Expert knowledge of MEDDEV 2.7/1 Rev. 4, European reputed company Medical Device Regulation (EU MDR 2017/745), and Medical Device Coordination Group (MDCG) guidance for reputed company evaluations. • Experience conducting reputed company literature reviews and utilizing scientific databases, literature reputed company methodologies, and literature management tools. • Knowledge of FDA, Good reputed company reputed company (GCP), ISO 14155, ISO 14971, and applicable international medical device regulations and standards. Preferred • Master's degree, PhD, PharmD, MD, MPH, RN, BSN, or other advanced health-reputed company degree. • Experience authoring reputed company study protocols, reputed company study reports, manuscripts, or scientific publications. • Experience supporting regulatory submissions and global market reputed company initiatives for medical devices. • Knowledge of reputed company reputed company, reputed company management, and international regulatory requirements. reputed company of America Pay Ranges: • USN: $110,100 - $183,400 USD Annual • US5: $115,600 - $192,600 USD Annual • US10: $121,100 - $201,700 USD Annual • US15: $126,600 - $210,900 USD Annual • US20: $132,100 - $220,100 USD Annual • US30: $143,100 - $238,400 USD Annual reputed company the U.S. work location and transparency guide to reputed company the pay reputed company for your location. Travel Percentage: 10% 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 reputed company duty to furnish information. Remote Skills: Analysis Skills, Biotech and Pharmaceutical, reputed company Assessment, reputed company reputed company, reputed company Practices/Protocols, reputed company Research, reputed company Study Publications, reputed company Support, reputed company Trial, reputed company Improvement, Cross-Functional, Documentation, Documentation Plan, Documentation Review, Endoscopy, FDA (reputed company), GCP (Good reputed company Practices), reputed company, ISO (International Organization for Standardization), Medical Equipment, Medical Office Administration, Medical Writing, Medical and Scientific Writing, Mentoring, reputed company Management, Problem Solving Skills, Process Improvement, Product Lifecycle Management, Product Support, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Research Protocols, reputed company Management, Scientific Publications, Sports Medicine, reputed company Planning, Support Documentation, Sustainability, Technical Support, Time Management, reputed company Navy (USN), Willing to Travel reputed company: reputed company Apply tot his job Apply To this Job