{"id":1699932,"url":"https://alion.io/job/hologic-regulatory-affairs-specialist-2","title":"Regulatory Affairs Specialist","company":{"id":720267,"name":"Hologic","domain":"hologic.com","url":"https://alion.io/company/hologic","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":79,"open_postings":12,"ghost_share":0,"stale_share":0.833,"repost_share":0,"time_to_fill_p50_days":38,"computed_at":"2026-10-26T05:57:25Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Diego, United States","Marlborough, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":85000,"max_usd":166000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":68},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Oracle","optional":false}],"status":"live","first_seen_at":"2026-09-10T13:26:28Z","employer_posted_date":"2026-09-10","last_verified_at":"2026-10-26T16:56:12Z","board_verified":true,"closed_at":null,"days_open":46,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":46},"description":"Regulatory Affairs Specialist manages assigned projects of moderate complexity which include international regulatory activities; on-market compliance reports or assessment of design changes, manufacturing process and labeling changes for regulatory reporting, as assigned. This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting.\nEssential Duties and Responsibilities\nParticipate in product development project teams which include new or existing products as the regulatory representative and provide guidance on global regulatory requirements for new/existing products\nAssess manufacturing process, design, and labeling changes regulatory assessments and global change management for manufacturing changes associated with the Cytology and Molecular product lines.\nPrepare and maintain international submission dossiers\nPrepare, compile and publish post-market regulatory submissions \nCompile and / or maintain Technical Documentations for IVD medical devices to support EU CE-Mark \nInteract with business partners to support ROW submissions for IVD medical devices (Asia Pacific, Latin America,Europe, the Middle East and Africa, Canada etc.).\nMonitor progress on key project deliverables and provide status updates to management on a regular basis.\nReview validation, clinical/R&D protocols and reports to be included or summarized in regulatory submissions\nInterface with product development teams/sustaining teams and regulatory authorities throughout the product lifecycle\nProvide recommendations for compliant advertising/promotional materials\nKeep informed of new and revised regulations; disseminate information as appropriate.\nManage relationships with international customers (e.g., regulatory agencies, distributors, etc.)\nDemonstrate in-depth understanding of advanced technical/scientific principles related to MDR / IVD reagent chemistry, laboratory automation, and software components of MDR / IVD medical devices\nPrepare/manage internal procedures for continuous process improvement. Provide guidance on new or revised procedures and policies (as assigned). \nQualifications\nEducation & Experience\nBachelor's Degree required in the life sciences or engineering with a minimum of 4 years direct experience in Regulatory Affairs (within an MDR / IVD industry preferred). \nMaster’s Degree and/or RAC with a minimum of 1 year direct experience in Regulatory Affairs within the MDR / IVD Industry \nSkills\nDemonstrated ability to coordinate complex projects. \nUnderstanding of medical device and IVD regulations in US and international markets. \nCapacity to communicate regulations to technical functions within the company \nUnderstanding of product life cycle process, design control and/or risk management.\nExperience with document control systems such as Agile and Oracle \nAbility to work independently and effectively\nStrong oral and written communication skills with ability to write detailed information for submissions\nGood analytical and problem solving skills.\nAbility to make and keep time bound commitments for project completion\nProficient ability to read, analyze and interpret technical documents, professional journals, technical procedures and government regulations\nStrong interpersonal skills including the ability to interact with all levels of the company\nAbility to manage relationships international customers (e.g., regulatory agencies, distributors, etc.)\nStrong computer skills including Microsoft Office\nThe annualized base salary range for this role is $74,100 - $116,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.\nWhy join Hologic?\nWe are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.\nAgency and Third-Party Recruiter Notice\nAgencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.\nHologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.","description_format":"text","description_chars":4573,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Hospitals & Health Systems"],"lifecycle":[{"event":"open","at":"2026-10-02T13:01:36Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 30 · green card filings: 7","filings_12m":30,"filings_prev_12m":31,"green_card_filings_12m":7,"median_offered_wage_usd":133986,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":21,"band":"cold","label":"Long shot","p_open":1,"p_active":0.476,"p_room":0.44,"age_days":45,"expected_fill_days":38,"reasons":["conf:9","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-26T05:57:25Z"},"pay":null,"html_url":"https://alion.io/job/hologic-regulatory-affairs-specialist-2","json_url":"https://alion.io/job/hologic-regulatory-affairs-specialist-2.json","meta":{"generated_at":"2026-10-26T20:13:37Z","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":27317,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"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":720267},"rest":"https://alion.io/mcp/rest/get_company?id=720267"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhologic-regulatory-affairs-specialist-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%2Fhologic-regulatory-affairs-specialist-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%2Fhologic-regulatory-affairs-specialist-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/hologic-regulatory-affairs-specialist-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhologic-regulatory-affairs-specialist-2"}]}