{"id":1141484,"url":"https://alion.io/job/coopervision-senior-regulatory-affairs-specialist","title":"Senior Regulatory Affairs Specialist","company":{"id":253547,"name":"CooperVision","domain":"coopervision.com.sg","url":"https://alion.io/company/coopervision","size_band":"1001-5000","is_staffing_agency":false,"is_intermediary":false,"ats_vendor":"Oracle","truth_index":{"grade":"A","score":93,"open_postings":19,"ghost_share":0,"stale_share":0.474,"repost_share":0,"time_to_fill_p50_days":3,"computed_at":"2026-09-24T05:45:00Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"hiring_geo_confidence":"structured","locations":["Gurgaon, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":19500,"max_usd":46000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":147},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-23T09:56:51Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-09-24T02:43:39Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Support new product registrations and license renewals for medical device and fertility products in India, Sri Lanka, and Nepal, ensuring compliance with applicable local regulatory requirements. Act as the primary regulatory liaison with external consultants, distributors, and local health authorities, coordinating all regulatory-related communications, submissions, responses, and follow-ups. Ensure timely progression of regulatory activities, proactive issue resolution, and alignment between internal stakeholders and external parties to support uninterrupted market access and regulatory compliance.\n Provide regulatory input and guidance for assigned countries on regulatory-related matters.\n\nEnsure product registrations are reviewed, maintained, and renewed in accordance with local regulatory requirements.\n\nProvide regular updates to the management team on product registration and renewal status and proactively propose action plans in the event of delays.\n\nCollaborate closely with regional and global teams on regulatory documentation and Regulatory Information Management Systems (RIMS).\n\nPrepare, coordinate, and submit regulatory applications to local health authorities and/or distributors, as appropriate.\n\nSupport regulatory strategy development for new products, product changes, and market expansions in assigned countries.\n\nTrack and monitor regulatory timelines and commitments, escalating risks and constraints proactively to minimize delays.\n\nCoordinate with Quality, Manufacturing, Supply Chain, and Commercial teams to ensure regulatory compliance and uninterrupted product supply.\n\nMaintain awareness of local regulatory updates, guidelines, and new regulations, including their implementation and impact on the business.\n\nEstablish and maintain relationships with local medical device industry associations and participate in discussions on regulatory policies, where applicable.\n\nSupport internal regulatory audits as well as external regulatory or compliance audits, as required.\n\nSupport other relevant regulatory affairs activities as assigned.\n\nTravel:\n5 %\n Knowledge, Skills and Abilities:\n3 -5 years of experience in Medical Device Regulatory Affairs\nKnowledge on GDPMD would be an advantage\nKnowledge on post market reporting would be an advantage\nMandatory knowledge for regulatory submission in India\nAdditional knowledge of regulatory environment in Sri Lanka and Nepal would be an advantage\nWork Environment:\nOffice based\nExperience:\n3 - 5 years experience in Medical Device Industry\nEducation:\nBachelor’s degree in any Science related field","description_format":"text","description_chars":2585,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"India","iso":"IN","kind":"country"},{"name":"Nepal","iso":"NP","kind":"country"},{"name":"Sri Lanka","iso":"LK","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Consumer Goods","Health Care","Eyewear","Vision Care & Ophthalmology"],"lifecycle":[{"event":"open","at":"2026-09-23T12:12:27Z"}],"liveness":{"score":87,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.874,"p_room":1,"age_days":0,"expected_fill_days":3,"reasons":["conf:3","velocity","win:early","comp:brand"],"computed_at":"2026-09-24T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/coopervision-senior-regulatory-affairs-specialist","json_url":"https://alion.io/job/coopervision-senior-regulatory-affairs-specialist.json","meta":{"generated_at":"2026-09-24T11:26:31Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}