Regulatory Affairs Specialist – FDA Medical Device Regulation

Stelle nicht auf LinkedIn

🕒 vor 1 Monat

🇺🇸 Vereinigte Staaten – Remote

💵 $73.759 - $91.200 / Jahr

⏰ Vollzeit

🟢 Junior

🟡 Mittelstufe

🚔 Compliance

👻 Geisterscore 5%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

Jetzt Bewerben

Ähnliche Remote-Jobs finden

E-Mail-Benachrichtigung für neue Jobs einrichten

📊 Überprüfen Sie Ihre Lebenslauf-Bewertung für diese Stelle

Verbessern Sie Ihre Chancen auf ein Vorstellungsgespräch, indem Sie Ihre Lebenslauf-Bewertung vor der Bewerbung überprüfen.

Lebenslauf hochladen

FUJIFILM Corporation

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1934

🏭 Fertigung

🏥 Gesundheitswesen

Manufacturing • Healthcare • Electronics

Die FUJIFILM Corporation ist ein globales Unternehmen, das 1934 gegründet wurde und in verschiedenen Bereichen tätig ist, darunter Gesundheitswesen, Elektronik und Bildgebung. Als umfassendes Gesundheitsunternehmen entwickelt FUJIFILM ein breites Spektrum an Geschäftsfeldern in den Bereichen Prävention, Diagnose und Behandlung. Darüber hinaus legt das Unternehmen großen Wert auf ökologische Nachhaltigkeit durch verbesserte industrielle Effizienz und bewahrt Erinnerungen durch Film und Fotografie, bereichert emotionale Leben und menschliche Verbindungen.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

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