Senior Regulatory Affairs Specialist

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🔥 7 minutes ago

🌐 Hong Kong, Malaysia, +2 more countries – Remote

🇭🇰 Hong Kong – Remote 🇲🇾 Malaysia – Remote 🇹🇭 Thailand – Remote 🇸🇬 Singapore – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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Accuray

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1990

🏭 Manufacturing

🏥 Healthcare

💊 Pharmaceuticals

💰 Post-IPO Debt on 2016-01

Manufacturing • Healthcare • Pharmaceuticals

Accuray is dedicated to creating innovative radiotherapy cancer treatments. They focus on expanding the curative power of radiation therapy, particularly in the fields of oncology and medical devices, with specialized technologies like CyberKnife, Radixact, and TomoTherapy. Accuray aims to improve as many lives as possible through their advanced radiosurgery and radiation therapy solutions.

📋 Description

• Prepare, submit, and maintain regulatory applications for premarket approvals and licenses in designated countries • Develop and execute regional regulatory strategies and submission plans aligned with business objectives, timelines, and risk • Represent Accuray with global device regulatory authorities for registrations, regulatory inquiries, reporting, and recalls • Engage and manage regulatory agents or authorized representatives across multiple countries • Create and maintain technical documentation across the product lifecycle • Develop, maintain, and improve regulatory procedures, templates, and submission tools • Provide regulatory intelligence and interpret evolving regulations and standards • Serve as a Regulatory Affairs subject matter expert on cross-functional teams supporting product launches and sustaining • Assess regulatory impact of design, manufacturing, software, and labeling changes • Support commercial readiness by maintaining product registration status and regulatory constraints • Support internal and external audits, inspections, and document legalization as needed

🎯 Requirements

• Bachelor’s degree in a scientific, engineering, or related discipline (or equivalent experience) • 7+ years of experience in Regulatory Affairs or Quality Assurance within a medical device development and manufacturing environment • Experience authoring and leading regulatory submissions for medical devices in major markets such as the U.S., EU, China, and Japan • Strong working knowledge of international medical device regulations and dossier frameworks, including IMDRF, EU MDR, ASEAN, EAEU, STED, and Essential Principles • Working knowledge of ISO 13485 and MDSAP with experience supporting audits • Proven experience partnering cross-functionally and globally in a matrixed environment • Excellent written and verbal communication skills, including communication with health authorities • Strong organizational skills and attention to detail; ability to manage multiple priorities and timelines • Strong interpersonal and cross-cultural skills • Ability to travel occasionally, domestically and internationally • Permanent work authorization in the country of application without sponsorship

🏖️ Benefits

• Comfortable and climate-controlled indoor workspace • Regular business hours and a consistent, predictable work routine • Inclusive and collaborative work environment • Consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status