Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Hong Kong, +3 more states.

📋 Description

• Prepare, submit, and manage regulatory applications for premarket approvals and licenses in specified countries.

• Develop and implement regional regulatory strategies and submission plans that align with business goals, timelines, and risk assessments.

• Act as the representative for Accuray with global device regulatory bodies regarding registrations, regulatory inquiries, reporting, and recalls.

• Engage and oversee regulatory agents or authorized representatives in various countries.

• Create and sustain technical documentation throughout the product lifecycle.

• Develop, maintain, and refine regulatory procedures, templates, and submission tools.

• Provide regulatory intelligence and interpret changing regulations and standards.

• Serve as a subject matter expert in Regulatory Affairs on cross-functional teams that support product launches and ongoing operations.

• Evaluate the regulatory implications of design, manufacturing, software, and labeling modifications.

• Facilitate commercial readiness by ensuring product registration status and adhering to regulatory limitations.

• Assist with internal and external audits, inspections, and document legalization as required.

⛳️ Requirements

• Bachelor’s degree in a scientific, engineering, or related field (or equivalent experience).

• Over 7 years of experience in Regulatory Affairs or Quality Assurance within a medical device development and manufacturing setting.

• Proven experience in authoring and leading regulatory submissions for medical devices in key 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.

• Familiarity with ISO 13485 and MDSAP, along with experience in supporting audits.

• Demonstrated experience collaborating cross-functionally and globally in a matrixed organization.

• Excellent written and verbal communication skills, particularly in communications with health authorities.

• Strong organizational abilities and meticulous attention to detail; capable of managing multiple priorities and deadlines.

• Strong interpersonal and cross-cultural communication skills.

• Willingness to travel occasionally, both 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 workplace culture.

• Consideration is given without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.