{"id":2991130,"url":"https://alion.io/job/apple-india-principal-regulatory-associate-2","title":"India Principal Regulatory Associate","company":{"id":12,"name":"Apple","domain":"apple.com","url":"https://alion.io/company/apple","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Apple Jobs","truth_index":{"grade":"A","score":91,"open_postings":913,"ghost_share":0.001,"stale_share":0.157,"repost_share":0.003,"time_to_fill_p50_days":98,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Gurgaon, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":35000,"max_usd":82000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":137},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"EU MDR","optional":true}],"status":"live","first_seen_at":"2026-09-09T06:39:24Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-10-28T16:48:46Z","board_verified":true,"closed_at":null,"days_open":49,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":49},"description":"Imagine what you could do here. At Apple, excellent ideas have a way of becoming great products, services, and customer experiences. Bring passion and dedication to your job, and there’s no telling what you could accomplish. The people at Apple don’t just build products - we craft the kind of wonder that’s revolutionised entire industries.\nThe  Health group is looking for a Principal Regulatory Affairs Associate to help drive strategy, submissions, and policy for health products in India and surrounding geographies. If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient team who works closely together to build relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands. We come to Apple to think creatively about how to launch products within a rigorous regulatory structure for medical devices.\nDescription\nYou will represent the RA/QA team on a diverse array of regulatory submissions and policy initiatives with the goal of obtaining approvals for new technologies and making an impact in health policy. You will demonstrate the ability to develop a variety of solutions to regulatory challenges and will exercise independent judgment in settling and communicating appropriate regulatory action and requirements. This role will involve assessment of regulatory impact for new and modified Class A, B, and C products including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans in India and surrounding geographies.\nMinimum Qualifications\nBachelor's in Mechanical/Electrical/Biomedical/Computer Science degree or equivalent in any engineering discipline\n10+ years of medical device experience in a regulatory role, with at least 5+ years as a principal, manager or lead.\nSignificant experience in leading interactions with CSDSCO.\nSignificant experience preparing regulatory filings including pre-submissions and Subject Expert Committee (SEC) meetings.\nExperience driving policy initiatives in the medical device and Software as a Medical Device space.\nExpertise in crafting policy and advocacy positions, memos, and briefing documents.\nStrong working knowledge of CDSCO regulations that affect Class A, B and C devices.\nExperience with Software as a Medical Device (SaMD) and algorithm- or sensor-based products, including how regulatory strategy interacts with clinical study design and algorithm performance.\nAbility to be onsite; this role is a hybrid, in-person position.\nPreferred Qualifications\nGlobal regulatory strategy experience (e.g., EU MDR) is a strong plus.\nDemonstrable background in being autonomous and being able to clearly work towards established goals and initiatives with minimal oversight.\nWorking as part of a globally dispersed team.\nProven competence in determination of appropriate global regulatory requirements for new products or product changes.\nPartnering with and across engineering teams to set regulatory strategy.\nStrong organisational and management skills.\nExcellent communication skills, both verbal and written","description_format":"text","description_chars":3165,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Operating Systems","Laptops","Smartwatches & Fitness Trackers","Tablets"],"lifecycle":[{"event":"open","at":"2026-10-21T09:51:22Z"}],"visa":[],"liveness":{"score":69,"band":"ok","label":"Likely open","p_open":1,"p_active":0.955,"p_room":0.72,"age_days":48,"expected_fill_days":98,"reasons":["conf:3","urgency","velocity","win:mid","crowd:brand"],"computed_at":"2026-10-28T05:59:10Z"},"pay":null,"html_url":"https://alion.io/job/apple-india-principal-regulatory-associate-2","json_url":"https://alion.io/job/apple-india-principal-regulatory-associate-2.json","meta":{"generated_at":"2026-10-28T20:12:05Z","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":27984,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"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":12},"rest":"https://alion.io/mcp/rest/get_company?id=12"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fapple-india-principal-regulatory-associate-2"},{"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%2Fapple-india-principal-regulatory-associate-2"},{"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%2Fapple-india-principal-regulatory-associate-2"},{"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/apple-india-principal-regulatory-associate-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fapple-india-principal-regulatory-associate-2"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2991130}},{"tool":"search_jobs","arguments":{"company":"apple.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2991130},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); 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