{"id":2430941,"url":"https://alion.io/job/vision-rt-regulatory-affairs-quality-manager","title":"Regulatory Affairs & Quality Manager","company":{"id":2235474,"name":"Vision RT","domain":"visionrt.com","url":"https://alion.io/company/visionrt","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":null},"role":"Public Policy","role_family":"Public Policy","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Shanghai, China"],"countries":["CN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":35000,"max_usd":92000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":75},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-09-02T10:38:13Z","employer_posted_date":"2026-09-02","last_verified_at":"2026-10-20T04:05:10Z","board_verified":true,"closed_at":null,"days_open":47,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":47},"description":"About the role\n**Candidate MUST be a resident of Shanghai for regulatory reasons**\nThe RA/QA Manager is responsible for driving Vision RT's product licensing strategy in China, including domestic and import registrations, and for acting as Quality Representative for Vision RT Shanghai. Forming part of the China management team, the RA/QA Manager works closely with QRC, clinical, customer support and sales colleagues in China, the wider APAC region and at Vision RT headquarters in the UK to implement Vision RT's high quality standards and business strategy.\nKey responsibilities will include\nLead quality management and regulatory affairs for Vision RT Shanghai’s activities related to its designation as Vision RT Ltd.’s China Agent, product licensing, and importation, distribution and post-market customer support of Class III medical devices:\nAct as management representative within Vision RT Shanghai’s Quality Management System, responsible for post-market surveillance, legal compliance, regulatory registration management and liaison with the city, provincial and national NMPA.\nPost-market surveillance:\nHandle and maintain customer complaints and other product defect reports in accordance with the QMS and regulatory requirements.\nReview post-market data for reportable complaints and trends and follow procedures for reporting to the manufacturer and NMPA.\nPrepare and submit annual self-inspection reports to the NMPA.\nLegal compliance:\nManage adverse events and field actions, ensuring that they are reported in compliance with NMPA requirements.\nEnsure that accurate records of adverse events and field actions are maintained in accordance with the QMS and regulatory requirements.\nRegulatory registration management:\nDevelop and implement product registration strategies for Vision RT’s portfolio of Class III medical devices made in China and the UK.\nLiaise with the foreign manufacturer to ensure all medical device licences are in place and maintained.\nLiaison with the city, provincial and national NMPA:\nLiaise with the NMPA in Shanghai, Beijing and national level to ensure all required medical device and facility licenses for Vision RT’s products and operations in China are in place and maintained.\nThis role requires China and international travel.\nEssential Skills & Experience\nMinimum 5 years of experience in a China quality or regulatory role in medical devices.\nMandatory: Experience with Class III medical devices. Strong background in NMPA regulatory requirements and ISO 13485. Experience leading audits and interacting with the NMPA.\nTechnical skills and training\nNMPA regulations for Class III medical devices.\nAbility to use Microsoft Word, Excel and Outlook and confident in general computer usage.\nExcellent written and verbal communication skills in Mandarin (fluent) and English (minimum C1 level).\nStrong leadership, analytical thinking, and problem solving abilities.\nExcellent report-writing and presentation skills.\nMust be able to render clear and accurate judgements.\nDesirable Skills & Experience\nBachelor’s degree or higher in Engineering, Biomedical Engineering, Quality Management, Life Sciences, or a related field.\nISO 13485 and China GMP, GDP.","description_format":"text","description_chars":3202,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"China","iso":"CN","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Higher Education","Hospitals & Health Systems"],"lifecycle":[{"event":"open","at":"2026-10-13T09:03:55Z"}],"visa":[],"liveness":{"score":35,"band":"fade","label":"Fading","p_open":1,"p_active":0.639,"p_room":0.55,"age_days":47,"expected_fill_days":33,"reasons":["conf:1","win:tail"],"computed_at":"2026-10-20T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/vision-rt-regulatory-affairs-quality-manager","json_url":"https://alion.io/job/vision-rt-regulatory-affairs-quality-manager.json","meta":{"generated_at":"2026-10-20T06:30:37Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":7106,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-21T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2235474},"rest":"https://alion.io/mcp/rest/get_company?id=2235474"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fvision-rt-regulatory-affairs-quality-manager"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fvision-rt-regulatory-affairs-quality-manager"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fvision-rt-regulatory-affairs-quality-manager"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/vision-rt-regulatory-affairs-quality-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fvision-rt-regulatory-affairs-quality-manager"}]}