{"id":2644122,"url":"https://alion.io/job/verathon-manager-regulatory-affairs","title":"Manager, Regulatory Affairs","company":{"id":2622434,"name":"Verathon","domain":"verathon.com","url":"https://alion.io/company/verathon-com","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"role":"Public Policy","role_family":"Public Policy","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bothell, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":116581,"max":163567,"currency":"USD","period":"year","gross":null,"usd_annual":163567},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-15T19:37:31Z","employer_posted_date":"2026-10-15","last_verified_at":"2026-10-20T06:12:19Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Company Overview\nVerathon is a global medical device company committed to being a trusted partner to our customers and advancing patient care through innovative Airway Management and Urology solutions. For more than 40 years, we have worked alongside healthcare professionals to understand their needs and deliver high-quality technologies that provide lasting clinical and economic value.\nOur portfolio includes leading GlideScope® video laryngoscopy and BFlex™ bronchoscopy solutions, BladderScan® bladder volume measurement, and a growing range of single-use Urology solutions. Behind our innovations is a diverse, global team united by a commitment to our customers, collaboration, and improving patient care.\nVerathon, a business unit of Roper Technologies, is headquartered in Bothell, Washington, with international subsidiaries in Canada, Europe, and Asia Pacific.\nOverview\nVerathon ® is looking for a Manager, Regulatory Affairs to become the newest member of our Regulatory Affairs and Quality Assurance Team located in our Bothell, WA headquarters. This role is hybrid onsite.\nThe Manager, Regulatory Affairs leads the Regulatory Affairs function, managing the discipline through Regulatory Affairs Specialists and, as the team scales, subordinate supervisors responsible for obtaining and maintaining market authorizations across Verathon’s global device portfolio. This manager serves as the primary regulatory owner for FDA 510(k) submissions and global registration activities, providing strategic oversight, technical review, and team development. This role collaborates across Engineering, Clinical Affairs, Quality and Commercial teams. This role reports to the Director of Regulatory Affairs.\nResponsibilities\n510(k) Strategy and SubmissionsOwn the end-to-end lifecycle of FDA 510(k) submissions across Verathon’s product lines, including predicate selection, substantial equivalence argumentation, and eSTAR preparation.\nDirect team preparation of 510(k) summaries, performance testing summaries, SE comparison tables, and supporting technical documentation.\nLead response strategy for FDA Additional Information requests and deficiency letters, coordinating cross-functional inputs under compressed timelines.\nEvaluate eligibility for Traditional, Abbreviated, and Special 510(k) pathways and recommend the appropriate submission type based on device changes and applicable FDA guidance.\nMaintain awareness of evolving FDA guidance and De Novo precedents affecting the device categories in Verathon’s portfolio.\n\nGlobal Registration ManagementOversee international registration activities across applicable global markets.\nManage registration timelines, distributor relationships, and country-specific documentation packages.\nEnsure post-market registration maintenance activities including renewals, and Market expansions and Product Change Notifications (PCNs) are filed on schedule.\nCoordinate with regional distributors and in-country agents to satisfy local labeling, language, and technical file requirements.\n\nTeam Leadership and DevelopmentManage, mentor, and develop a team of Regulatory Affairs Specialists, setting clear performance expectations, conducting regular 1:1s, and supporting professional growth.\nAssign and prioritize workloads across the team to align with submission timelines, regulatory milestones, and business objectives.\nBuild team capability in technical writing, standards interpretation, and regulatory strategy through structured coaching and training.\nPartner with the Associate Director to identify staffing needs and contribute to workforce planning.\nOwn budget planning and tracking for the Regulatory Affairs function, including headcount planning and vendor and consultant spends.\n\nQuality System and ComplianceAuthor and maintain regulatory SOPs, work instructions, and Letter to File assessments within Verathon’s QMS.\nEnsure regulatory activities and are documented and traceable per QMS requirements, supporting both internal audits, and Notified Body or MDSAP surveillance audits.\nIdentify and escalate regulatory risks, and change assessment triggers in a timely manner.\nTranslate Regulatory Affairs functional plans into operational processes, contribute to annual regulatory strategy and planning, and advise senior leadership on regulatory risk affecting business objectives.\n\nQualifications\nBachelor’s degree in a scientific or engineering discipline (or equivalent experience).\n3 to 5+ years of direct people management experience and 8+ years of regulatory experience with a regulated quality environment.\n8+ years of related experience within a regulated quality environment, including people management.\nDemonstrated experience preparing and managing traditional 510(k)s independently, including substantial equivalence argumentation, performance testing summaries, and FDA deficiency responses.\nWorking knowledge of FDA 21 CFR Part 807, 820, 801, and applicable FDA guidance documents (De Novo, Special 510(k), Predetermined Change Control Plans).\nExperience with FDA eSTAR submission format.\nPreferred direct experience with EU MDR Technical File preparation, Notified Body interactions, and EUDAMED registration workflows.\nPreferred RAC certification.\nFrequent interaction with external stakeholders, including FDA reviewers, Notified Body auditors, and international distributors, is a core expectation of this role.\nMust be a critical thinker, detailed oriented with strong, structured, critical thinking skills, able to oversee multiple tasks for several projects or base business deliverables and effectively balance priorities.\nMust have desire to work in a highly collaborative, productive, and empowered team environment.\n\nUp to 10% of international travel required to support Verathon facilities and partners globally.\n\nSalary range - $116,581.00 - $163,567.00 (Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range). \nFull-time employees who are not on a commission plan are eligible for Verathon’s annual bonus plan based on company and individual performance.\nVerathon provides a competitive benefits package including medical, dental, vision, basic life insurance, paid holidays, paid time off and a 401(k) matching plan. For more information, please visit our complete Benefits Summary at https://www.verathon.com/sites/default/files/2026-02/US_HQ_Employee_Benefits_Summary.pdf.\nEEO\nResearch shows that women and underrepresented groups tend to apply to jobs only when they check every box on a job posting. If you’re currently reading this and hesitating to click “Apply” for that reason, we encourage you to go for it! Even if you are not a match for this role, we may have another opportunity that may be a great fit. Verathon is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions and perspectives will build a strong foundation for success. In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Verathon will be based on merit, qualifications, and abilities. Verathon does not discriminate in employment opportunities or practices on the basis of race, color, religion, sexual orientation, gender identity, national origin, age, disability, or any other characteristic protected by law.","description_format":"text","description_chars":7388,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":5,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["Life insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Contract Manufacturing","Health & Medical Electronics"],"lifecycle":[{"event":"open","at":"2026-10-15T19:37:31Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":4,"expected_fill_days":35,"reasons":["conf:3","velocity","win:early"],"computed_at":"2026-10-20T05:45:00Z"},"pay":{"stated_usd_annual":163567,"is_top_pay":true},"html_url":"https://alion.io/job/verathon-manager-regulatory-affairs","json_url":"https://alion.io/job/verathon-manager-regulatory-affairs.json","meta":{"generated_at":"2026-10-20T11:12:16Z","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":12299,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-21T00:00:00Z"}},"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":2622434},"rest":"https://alion.io/mcp/rest/get_company?id=2622434"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fverathon-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%2Fverathon-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%2Fverathon-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/verathon-manager-regulatory-affairs\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fverathon-manager-regulatory-affairs"}]}