{"id":2584805,"url":"https://alion.io/job/philips-regulatory-affairs-manager","title":"Regulatory Affairs Manager","company":{"id":13838,"name":"Philips","domain":"philips.com","url":"https://alion.io/company/philips-2","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Public Policy","role_family":"Public Policy","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Shenzhen, China","Hong Kong"],"countries":["CN","HK"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":39000,"max_usd":88000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":321},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-15T03:30:53Z","employer_posted_date":"2026-10-15","last_verified_at":"2026-10-19T07:34:40Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Job Title\nRegulatory Affairs ManagerJob Description\nPurpose:\nIn this role, you have the opportunity to make life better through supporting the Personal Health innovation teams in bringing products to the market, complying with external regulations and standards and with company product safety & compliance policies. You will be guiding the business through the regulatory landscape, all within a competitive environment. Your role is end to end responsibility for class I and class II medical device product group and non-medical consumer product group of the same technology as the Medical device.\nYour responsibilities:\nParticipation in Product Development Teams (medical device and consumer products).\nTake ownership of regulatory submissions such as but not limited to initial registrations, changes/variations, and international renewals.\nApprobation plans, Regulatory Strategy Plans\nWork with applicable test houses, notified body and other regulatory authorities.\nResponsible for the preparation and maintenance of the European Technical File for CE marking\nResponsible for end to end 510(k) clearance in the U.S Experience with EU MDR\nInternational medical device submissions\nYou are a part of:\nBusiness Personal Health - Mother & Childcare / Women’s Health and work in our Research & Development Netherlands organization located in Eindhoven. We develop medical and non-medical products and are responsible for innovation, product research, development, industrialization, and post market activities. You are part of a multidisciplinary organization with over 300 colleagues where the colleagues in Drachten and Eindhoven (Netherlands) as well as Hong Kong and Shenzhen. In this role you will drive from within early collaboration with the R&D team ensuring that our products meet the Safety, Compliance and Regulatory and set up to achieve successful market access. You report to Team lead of RA, MCC Business in Netherland.\nYou're the right fit if:\nUniversity Degree\n5 years of experience in product development projects of electronics in medical devices (consumer products a plus)\nExperienced in Risk Management (IEC 14971)\n(Previous) experience with successful 510k clearance\n(Previous) experience with MDD and MDR Technical file for Class I and Class IIa products\nExperience with EUDAMED, UDI requirements.\nProven analytic capabilities and product knowledge - system thinking.\nA network-oriented mind-set and ability to interact with different business functions at all levels.\nTechnical writing and project management skills\nVery good English and Chines Skills required\nFurthermore, you are:\nconceptual, analytical, data driven, and also hands-on, getting things done mentality.\na subject leader and also a team player\na good communicator skilled in managing interpersonal processes.\nquality oriented and solution seeking mind-set.","description_format":"text","description_chars":2847,"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":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health & Medical Electronics","Respiratory & Sleep Devices","Patient Monitoring","EHR & Clinical Software"],"lifecycle":[{"event":"open","at":"2026-10-15T03:30:53Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":4,"expected_fill_days":28,"reasons":["conf:22","velocity","win:early","comp:brand"],"computed_at":"2026-10-19T05:45:15Z"},"pay":null,"html_url":"https://alion.io/job/philips-regulatory-affairs-manager","json_url":"https://alion.io/job/philips-regulatory-affairs-manager.json","meta":{"generated_at":"2026-10-19T09:28:43Z","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":6591,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-20T00:00:00Z"}},"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":13838},"rest":"https://alion.io/mcp/rest/get_company?id=13838"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fphilips-regulatory-affairs-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%2Fphilips-regulatory-affairs-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%2Fphilips-regulatory-affairs-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/philips-regulatory-affairs-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fphilips-regulatory-affairs-manager"}]}