{"id":928468,"url":"https://alion.io/job/medline-manager-regulatory-affairs","title":"Manager Regulatory Affairs","company":{"id":7482,"name":"Medline","domain":"medline.com","url":"https://alion.io/company/medline","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":110,"ghost_share":0.018,"stale_share":0.7,"repost_share":0.045,"time_to_fill_p50_days":31,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Biotech","role_family":"Biotech","seniority":"middle","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Eagan, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":116000,"max":174000,"currency":"USD","period":"year","gross":null,"usd_annual":174000},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-14T00:00:00Z","employer_posted_date":"2026-09-14","last_verified_at":"2026-11-05T07:17:48Z","board_verified":true,"closed_at":null,"days_open":52,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":52},"description":"Job Summary\nMedline Industries has an immediate opening for a Manager Regulatory Affairs at our Eagan, MI location. This role will work a hybrid work model. Oversee regulatory affairs for Medline product divisions.Responsible for leading the Regulatory Affairs team to develop regulatory strategies for domestic and international approvals of medical devices. Provide leadership and develop Regulatory Affairs professionals.\nJob Description\nMAJOR RESPONSIBILITIES:\nGuide regulatory and licensing decision-making processes based on relevant regulatory requirements of medical devices.\nComplete and maintain regulatory filings by leading internal groups, collaborating with external groups, providing direction to obtain supporting technical information, and implementing focused solutions for identified changes and challenges.\nOversee the communication of regulatory requirements to internal or external customers. Lead communication with critical regulators to respond to non-conformances, deficiencies, and questions.\nDevelop and implement processes and procedures to maintain regulatory compliance related to medical device pre and post market activities involving regulatory, R&D, quality and medical affairs.\nMonitor changes in the regulatory and legislative environment.\nRecommend regulatory pathways, strategies, solutions, and future actions for specific and diverse scenarios, accounting for business objectives and factors relevant to other departments/functional areas\nReview and provide direction to ensure supporting evidence meets appropriate regulatory requirements. Assess records against multiple requirements sources, including regulations, guidance documents, and standards utilized in various applicable markets that have been identified as applicable.\nManagement responsibilities include:\n--Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments\n--Day-to-day operations of a group of employees.\n--May have limited budgetary responsibility and usually contributes to budgetary impact;\n--Interpret and execute policies for departments/projects and develops.\n--Recommend and implement new policies or modifications to existing policies.\n--Provide general guidelines and parameters for staff functioning.\n--Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.\nMINIMUM JOB REQUIREMENTS:\nEducation:\nBachelor’s Degree in Regulatory Affairs, Life Sciences (e.g. biology, chemistry) or Engineering.\nCertification / Licensure:\nNone\nWork Experience:\nAt least 4 years of experience working in regulatory affairs for medical devices.\nKnowledge / Skills / Abilities:\nAbility to manage multiple projects and work in a fast paced, changing environment.\nAdvance skills in Word and Excel.\nStrong understanding of medical device regulations for pre-market approvals/clearances for medical device. Understanding of post- market regulatory requirements of medical device.\nSkill and ability to diagnose, isolate, and resolve complex issues and recommend and implement strategies to resolve problems.\nRequires the ability to present and communicate with various audiences (e.g. senior management and non-technical audiences).\nPosition requires up to 15% travel\nPREFERRED JOB REQUIREMENTS:\nEducation:\nNone\nCertification / Licensure:\nRAC Certification.\nWork Experience:\nExperience working with SAP.\nKnowledge / Skills / Abilities:\nExperience writing 510(k)s and CE technical files.\nExperience directly managing people including hiring, developing, motivating, and directing people as they work.\nExperience applying knowledge of EPA VOC, Prop 65, FIFRA, OSHA HAZCOM, CPSC, DOT, FDA, and/or VAWD.\nMedline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.\nThe anticipated salary range for this position:\n$116,000.00 - $174,000.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.\nOur benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.\nWe’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.\nMedline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.","description_format":"text","description_chars":5580,"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":["Health insurance","Hybrid work"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Medical Supplies & Consumables","Wound Care","Medical Equipment Distribution"],"lifecycle":[{"event":"open","at":"2026-09-15T09:35:10Z"}],"visa":[],"liveness":{"score":19,"band":"cold","label":"Long shot","p_open":1,"p_active":0.537,"p_room":0.36,"age_days":52,"expected_fill_days":31,"reasons":["conf:4","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-11-05T05:54:30Z"},"pay":{"stated_usd_annual":174000,"is_top_pay":true},"html_url":"https://alion.io/job/medline-manager-regulatory-affairs","json_url":"https://alion.io/job/medline-manager-regulatory-affairs.json","meta":{"generated_at":"2026-11-05T11:55:43Z","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":15198,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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":7482},"rest":"https://alion.io/mcp/rest/get_company?id=7482"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmedline-manager-regulatory-affairs"},{"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%2Fmedline-manager-regulatory-affairs"},{"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%2Fmedline-manager-regulatory-affairs"},{"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/medline-manager-regulatory-affairs\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmedline-manager-regulatory-affairs"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":928468}},{"tool":"search_jobs","arguments":{"company":"medline.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":928468},"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); https://alion.io/mcp with an Alion account has everything. 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