Regulatory Affairs Specialist – FDA Medical Device Regulation

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $73.8k - $91.2k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 0%

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FUJIFILM Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1934

🏭 Manufacturing

🏥 Healthcare

Manufacturing • Healthcare • Electronics

FUJIFILM Corporation is a global company established in 1934, operating in diverse fields including healthcare, electronics, and imaging. As a total healthcare company, FUJIFILM develops a wide range of businesses in prevention, diagnosis, and treatment. Additionally, the company focuses on environmental sustainability through improved industrial efficiency, while also capturing and preserving memories through film and photography, enriching emotional lives and human connections.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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