Senior Regulatory Affairs Specialist

🕒 Outubro 20

🤠 Texas – Remoto

🤠 Texas – Remote

💵 $124.000 - $170.500 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 0%

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• Aberta há 21 dias.
• As vagas desta empresa costumam ser preenchidas em 24 dias.

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Solventum

SiteLinkedInTodas as Vagas

10.000+ funcionários

🏥 Saúde

📦 Logística

💼 Consultoria

Healthcare • Logistics • Consulting

Solventum é uma empresa focada em saúde, conhecida por suas soluções inovadoras voltadas para melhorar os resultados dos cuidados médicos e odontológicos. A empresa oferece uma variedade de tecnologias médicas, incluindo cuidados avançados para feridas, soluções cirúrgicas e produtos de esterilização. A Solventum também fornece soluções avançadas para cuidados orais, serviços de tecnologia e informação em saúde, e produtos de purificação e filtração para aplicações biofarmacêuticas. Além disso, a Solventum dá forte ênfase à sustentabilidade e educação, oferecendo recursos e treinamento para profissionais de saúde em todo o mundo. Seu compromisso com a inovação e com a melhoria da saúde fez dela uma líder na indústria de saúde, dedicada a aprimorar a segurança dos pacientes e a eficiência dos cuidados médicos.

Descrição

• Lead a regulatory affairs team primarily supporting the Restorative Healing Technologies portfolio • Support early- and late-stage product development through critical milestones and regulatory activities leading to global product approvals • Support ongoing product compliance throughout the device lifecycle • Build strong relationships across stakeholders, management, and contract organizations • Develop a team with the capacity and competence to support business strategic plans • Develop and execute regulatory strategies for new product market authorizations, indications, and claims • Manage complex regulatory decision-making among cross-functional stakeholders • Represent Regulatory Affairs in global business and functional strategic meetings and forums • Perform regulatory assessments and determine registration plans with the business • Articulate global registration requirements and compile regulatory documents according to local requirements • Submit registration documents and follow through on evaluations until regulatory authorization is obtained • Act as the focal point for commercial support related to regulatory activities • Manage regulatory systems and tools, data tracking, and regulatory data integrity • Review advertising and promotional materials for alignment with cleared claims • Monitor new regulations and provide regulatory information, updates, and documentation • Support ISO 13485, MDSAP, and Technical Surveillance audits • Complete additional duties, responsibilities, or assigned projects

🎯 Requisitos

• Bachelor’s Degree or higher (completed and verified prior to start) AND seven (7) years of Regulatory Affairs experience within a regulated industry in a private, public, government or military environment OR High School Diploma/GED (completed and verified prior to start) AND eleven (11) years of Regulatory Affairs experience within a regulated industry in a private, public, government or military environment • Master’s Degree or higher in a scientific, engineering, regulatory, or quality discipline • Three (3) years of experience preparing and/or supporting regulatory submissions, including 510(k) submissions, EU MDR submissions, or other international medical device regulatory submissions • Three (3) years of experience supporting ISO 13485 and/or MDSAP audits • Experience supporting regulatory activities for negative pressure wound therapy devices and/or wound care medical devices • Experience supporting regulatory activities for absorbable wound care dressings and matrices • Experience supporting regulatory activities for electro-mechanical devices and/or embedded or stand-alone software medical devices • Must be legally authorized to work in country of employment without sponsorship for employment visa status

🏖️ Benefícios

• Medical, Dental & Vision • Health Savings Accounts • Health Care & Dependent Care Flexible Spending Accounts • Disability Benefits • Life Insurance • Voluntary Benefits • Paid Absences • Retirement Benefits • Up to 10% domestic/international travel opportunity

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