{"id":1054612,"url":"https://alion.io/job/medline-senior-regulatory-affairs-specialist-2","title":"Senior Regulatory Affairs Specialist","company":{"id":7482,"name":"Medline","domain":"medline.com","url":"https://alion.io/company/medline","size_band":"5000+","is_staffing_agency":false,"is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":48,"ghost_share":0,"stale_share":0.771,"repost_share":0,"time_to_fill_p50_days":26,"computed_at":"2026-09-24T05:45:00Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":92000,"max":138000,"currency":"USD","period":"year","gross":null,"usd_annual":138000},"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":"2026-09-25T03:28:11Z","board_verified":true,"closed_at":null,"days_open":11,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":11},"description":"Job Summary\nMedline Industries has an immediate opening for a Senior Regulatory Affairs Specialist with our Quality division. This role will be remote. Under limited supervision, the Senior Regulatory Specialist is responsible for planning and executing critical and complex global regulatory projects necessary to obtain and maintain global regulatory approvals.Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements.\nResponsible for developing solutions to re-solve complex regulatory issues and for leading multifunctional teams in high-priority projects.\nJob Description\nMAJOR RESPONSIBILITIES:\nIn support of business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s). Identify factors that could impact the success or viability of new product launch in assigned market(s). Monitor changes in regulations that impact current or future requirements and overall compliance.\nCommunicate requirements of regulations to internal or external customers. Recommend regulatory pathways, strategies, and solutions for specific products and scenarios.\nReview and provide direction to ensure supporting evidence meets appropriate regulatory requirements. Assess records against multiple requirements sources, including regulations, guidance documents, and standards.\nComplete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators.\nParticipate in the development, review, and substantiation of product labeling and claims.\nManage individual projects by providing direction on diverse regulatory pathways, defining timelines for tasks and project teams, and recommending future actions and solutions.\nAssist in the review and development of processes related to regulatory activities of responsibility\nAssist in the establishment and maintenance of department databases, logs, and files necessary for ensuring ongoing compliance.\nActively participate in internal and external audits when applicable.\nMINIMUM JOB REQUIREMENTS:\nEducation:\nB.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related field.\nCertification / Licensure:\nNone\nWork Experience:\n4 years of experience in regulatory affairs in the medical device industry supporting domestic or international markets.\nExperience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files.\nExperience preparing responses and communicating with regulatory agencies.\nKnowledge / Skills / Abilities:\nUnderstanding of the current Regulatory environment and demonstrating the ability to perform within.\nApplied knowledge of FDA regulations and guidelines.\nAbility to evaluate information to determine compliance with standards, laws, and regulations.\nPosition requires up to 10% travel\nPREFERRED JOB REQUIREMENTS:\nEducation:\nNone\nCertification / Licensure:\nNone\nWork Experience:\nNone\nKnowledge / Skills / Abilities:\nNone\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$92,000.00 - $138,000.00 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":5162,"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"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Manufacturing","Medical Devices","Logistics"],"lifecycle":[{"event":"open","at":"2026-09-19T01:42:10Z"}],"liveness":{"score":53,"band":"ok","label":"Likely open","p_open":1,"p_active":0.587,"p_room":0.9,"age_days":10,"expected_fill_days":26,"reasons":["conf:1","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-09-24T05:45:00Z"},"pay":{"stated_usd_annual":138000,"is_top_pay":false},"html_url":"https://alion.io/job/medline-senior-regulatory-affairs-specialist-2","json_url":"https://alion.io/job/medline-senior-regulatory-affairs-specialist-2.json","meta":{"generated_at":"2026-09-25T04:27:50Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":4836,"day_limit":5000,"remaining_today":164,"minute_limit":60,"resets_at":"2026-09-26T00:00:00Z"}}}