Regulatory Affairs Specialist – FDA Medical Device Regulation

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🕒 Agosto 21

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $73.759 - $91.200 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🚔 Conformidade

👻 Score fantasma 7%

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FUJIFILM Corporation

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1934

🏭 Manufatura

🏥 Saúde

Manufacturing • Healthcare • Electronics

A FUJIFILM Corporation é uma empresa global estabelecida em 1934, atuando em diversos campos, incluindo saúde, eletrônica e imagem. Como uma empresa de saúde total, a FUJIFILM desenvolve uma ampla gama de negócios em prevenção, diagnóstico e tratamento. Além disso, a empresa foca na sustentabilidade ambiental por meio da melhoria da eficiência industrial, enquanto também captura e preserva memórias através de filmes e fotografias, enriquecendo vidas emocionais e conexões humanas.

Descrição

• Provide Regulatory Affairs support to FUJIFILM Healthcare Americas Corporation • Support ongoing compliance with U.S. FDA medical device regulatory requirements, applicable ISO 13485 requirements, and other applicable laws, regulations, and standards • Serve as Designated Responsible Personnel for device marketing authorization and facility registration, including registration, listing, licensing, notification, and approval submissions • Participate with a regulatory authority or authorized representative in the Medical Device Single Audit Program (MDSAP) • Serve as Designated Joint Responsibility pursuant to Article 15 of the EU MDR • Perform pre-market U.S. FDA submissions, including 510(k) and PMA, according to the product plan • Advise design teams on when to submit a 510(k) for changes to existing medical devices • Communicate regulatory documentation conclusions for new products and supplier assessments to business units • Prepare EU technical documentation and international regulatory submissions • Evaluate incoming customer information, investigate and document escalated customer complaints, perform trend analysis, and maintain records • Confirm medical device reportability of potential adverse events and take appropriate action • Coordinate field action notifications, risk assessments, and corrections and removals • Collaborate with Customer Service, Service, Repair, R&D, Quality Assurance, Regulatory Affairs, and Sales • Perform Corrective and Preventive Action activities • Prepare QMS audit data and remediation documentation • Support import/export/customs activities • Prepare Management Review Meeting data • Attend department and company-wide meetings as needed • Perform other duties as assigned

🎯 Requisitos

• Bachelor's degree in related discipline and 2+ years of hands-on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment OR Regulatory Affairs Certification and 4+ years of hands-on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment • Broad knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807) • Knowledge of U.S. FDA import/export/customs regulations • Broad knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations) • Excellent leadership, communication, collaboration, team work and interpersonal skills • Ability to effectively communicate with staff members and business partners at all levels of the organization, both internal and external • Excellent computer and internet search skills • Strong ability to multi-task and meet business deadlines • Excellent organizational skills with an ability to think proactively and prioritize work • Ability to sit up 75-100% of applicable work time • Ability to use hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time • Ability to stand, talk, and hear for 75% of applicable work time • Ability to lift and carry up to ten pounds up to 20% of applicable work time • Close Vision: ability to see clearly at twenty inches or less • Occasional travel of up to 25% may be required • Willingness to comply with applicable COVID-19 testing, face covering, vaccination, and facility credentialing requirements where applicable

🏖️ Benefícios

• 8% Bonus opportunity • Medical • Dental • Vision • Life Insurance • 401k • Paid Time Off • Flexible environment • Reasonable accommodation in the application and selection process