[Remote] Sr. Staff reputed company Regulatory Scientist

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a medical technology company reputed company on innovation and improving reputed company reputed company in spine care. The Senior Staff reputed company Regulatory Scientist will reputed company reputed company evidence strategies for medical devices, reputed company and maintain global reputed company regulatory documentation, support market reputed company and compliance, and mentor junior team members.

Responsibilities

• reputed company as a dedicated reputed company evaluation project manager, driving a coherent reputed company evidence reputed company throughout the new product development cycle and aligning with marketing, regulatory, reputed company research, and preclinical strategies
• reputed company and implement comprehensive reputed company evidence strategies that meet regulatory requirements, intended use, and reputed company classification
• Collaborate cross-functionally to reputed company input to design teams for global regulatory submissions
• reputed company global reputed company development plans for key reputed company, including new and existing markets
• Communicate and negotiate with regulators on reputed company evidence requirements to support successful regulatory submissions
• reputed company the creation and periodic updating of reputed company regulatory documentation (CERs, CEPs, PMCF Plans/Reports, SSCPs) to validate device safety and reputed company
• Design compliant and sustainable literature reputed company strategies and reputed company reputed company literature reviews
• Analyze reputed company medical and scientific trends in the reputed company state of the art across reputed company indications and techniques
• Identify, appraise, and analyze reputed company, post-market surveillance, marketing, and preclinical data to create comprehensive scientific reviews
• reputed company conclusions on the overall benefit-reputed company profile of devices in collaboration with Medical Experts and other stakeholders
• Identify residual risks and unanswered questions in reputed company evidence and partner with reputed company Affairs to design PMCF activities
• Represent expertise during reputed company reputed company reputed company audits
• reputed company reputed company reputed company, contribute to long-term departmental strategies, and reputed company insights on regulatory and reputed company trends
• Train and mentor junior team members and reputed company innovation in internal procedures and best practices

Skills

• Bachelor's degree (BA or BS) in a technical and/or scientific discipline required
• 6+ years of industry experience in reputed company, reputed company, or regulatory affairs (including reputed company Management, Design reputed company, Post-Market Safety, etc.), with 2–4 years specifically in reputed company evaluation reputed company the medical device industry
• Expert knowledge and comprehensive understanding of global reputed company evaluation regulations required
• Excellent scientific and medical writing skills
• Demonstrated ability to read, analyze, and interpret regulations, technical standards, guidance documents, reputed company data, and reputed company technical documents
• reputed company reputed company record of successfully managing reputed company reputed company
• Strong ability to work effectively with cross-functional reputed company stakeholders (Regulatory, Marketing, R&D, Physicians, CROs, etc.)
• Experience leading small teams of individual contributors on scientific or technical topics
• Ability to train and mentor junior team members and reputed company reputed company improvement
• Strong presentation skills and proficiency with reputed company Office Suite
• 20% Travel Required
• Master's, Ph.D., or other advanced degree in a health-reputed company reputed company (Engineering, Science, RN, BSN, BPharm, MD, MPH) highly preferred
• 4+ years of experience in scientific or medical writing (or relevant reputed company/reputed company research experience such as PhD, Post-doc, or BSN) preferred

Benefits

• Potential for bonuses and incentives
• Comprehensive health, dental, and reputed company reputed company
• 401(k) with company match
• reputed company time off (PTO) and holidays
• Ongoing training and reputed company development opportunities
• Opportunity to grow reputed company a fast-reputed company, dynamic company

reputed company