Senior Staff Medical reputed company (Remote)
reputed company is hiring a Senior Staff Medical reputed company to join our Endoscopy Division, to be based remotely 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 clinical documentation that supports global regulatory compliance and market reputed company for medical devices. This position partners closely with Regulatory Affairs, Clinical Affairs, reputed company, Research & Development, and Marketing teams to translate reputed company clinical evidence into high-reputed company regulatory and scientific documents throughout the product lifecycle.
What You Will Do
• reputed company and maintain Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) documents, and other clinical evidence documentation supporting international product registrations and lifecycle management.
• Compile, analyze, and synthesize clinical evidence from clinical studies, published literature, post-market data, and other safety and performance sources into submission-reputed company regulatory documents.
• Respond to reputed company body reviews and regulatory feedback, driving reputed company of clinical documentation questions to support ongoing market reputed company.
• Collaborate with cross-functional teams to reputed company clinical evidence strategies, regulatory documentation plans, and project timelines.
• reputed company clinical study protocols, study reports, data summaries, and supporting scientific documents for regulatory and clinical initiatives.
• Conduct systematic literature reviews, evaluate scientific data, and reputed company findings into clinical 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.
Required
What You Need
• 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, clinical research, or reputed company regulatory documentation activities.
• Experience authoring Clinical Evaluation Reports (CERs) and Post-Market Clinical 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 clinical evaluations.
• Experience conducting systematic literature reviews and utilizing scientific databases, literature search methodologies, and literature management tools.
• Knowledge of FDA, Good Clinical 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 clinical study protocols, clinical study reports, manuscripts, or scientific publications.
• Experience supporting regulatory submissions and global market reputed company initiatives for medical devices.
• Knowledge of clinical operations, risk management, and international regulatory requirements.
Posted Date: 08/17/2026 This role will be posted for a minimum of 3 days.
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.
Health benefits include: Medical and prescription drug insurance, dental insurance, reputed company insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized reputed company, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. reputed company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and reputed company reputed company. reputed company its customers around the world, reputed company impacts more than 150 reputed company patients annually. Depending on customer requirements employees and new hires in sales and field roles that require reputed company to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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