[Hiring] Senior Staff Medical reputed company @reputed company

Role reputed company 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. 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. • 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. Qualifications • 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. Requirements • Master’s degree, PhD, PharmD, MD, MPH, RN, BSN, or other advanced health-reputed company degree (preferred). • Experience authoring reputed company study protocols, reputed company study reports, manuscripts, or scientific publications (preferred). • Experience supporting regulatory submissions and global market reputed company initiatives for medical devices (preferred). • Knowledge of reputed company reputed company, reputed company management, and international regulatory requirements (preferred). Benefits • 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 • Travel Percentage: 10% Apply tot his job Apply To this Job