{"id":1453573,"url":"https://alion.io/job/conmed-senior-manager-regulatory-affairs","title":"Senior Manager, Regulatory Affairs","company":{"id":1896673,"name":"CONMED","domain":"conmed.com","url":"https://alion.io/company/conmed-com","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Denver, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":138700,"max":215100,"currency":"USD","period":"year","gross":null,"usd_annual":215100},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":true,"relocation_package":false,"has_equity":true,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-09T00:00:00Z","employer_posted_date":"2026-09-09","last_verified_at":"2026-11-05T23:02:40Z","board_verified":true,"closed_at":null,"days_open":58,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":58},"description":"The Senior Manager Regulatory Affairs provides senior-level leadership for global regulatory strategy and execution for new, modified, and marketed CONMED medical devices. Directs regulatory submission strategy, agency engagement, labeling and claims review, product lifecycle support, inspection readiness, and regulatory process improvement across domestic and international markets. Partners with senior business, R&D, Clinical, Quality, Marketing, and Operations leaders to anticipate regulatory risks, influence product and portfolio decisions, and build a high-performing regulatory affairs team aligned to business objectives and applicable global requirements.\n***This is an on-site role, not hybrid or remote***\nKey Duties and Responsibilities\nLead and elevate global regulatory strategy for assigned product portfolios, including regulatory pathway decisions, submission plans, approval risks, and market-entry considerations for new products, design changes, and sustaining initiatives.\nDirect preparation, review, submission, and negotiation of regulatory applications with FDA, Notified Bodies, Health Canada, and other global regulatory authorities; ensure responses, commitments, and post-approval obligations are managed effectively.\nServe as a senior regulatory advisor to business and technical leaders by translating complex requirements into practical strategies that support product development timelines, commercial priorities, and compliant lifecycle management.\nMaintain a forward-looking understanding of medical device regulations, standards, guidance documents, and enforcement trends; assess business impact and lead implementation of regulatory expectations across teams.\nLead, coach, and develop regulatory affairs professionals and managers by setting expectations, building technical capability, strengthening succession depth, and ensuring resources are aligned to portfolio and business priorities.\nDrive cross-functional alignment with Marketing, R&D, Clinical, Quality, Operations, and Commercial partners to resolve regulatory issues, influence decision-making, and ensure regulatory deliverables are incorporated into project plans.\nOversee regulatory review of labeling, promotional, educational, and product communication materials to ensure claims, indications, risk information, and supporting documentation meet applicable regulatory requirements.\nStrengthen regulatory affairs procedures, inspection readiness, audit support, metrics, and continuous improvement initiatives to improve execution discipline, compliance, and scalability of the regulatory function.\nProvide clear communication to senior management on regulatory strategy, portfolio status, emerging risks, mitigation plans, approval timing, and potential business impact.\nIn addition to the main responsibilities listed above the Senior Manager is allowed to use discretion to add further duties and tasks based on the business needs which are not explicitly listed here.\nMINIMUM REQUIREMENTS\nBachelor’s degree in science, biomedical engineering, engineering, regulatory affairs, or a related technical discipline.\nMinimum 8 years of directly relevant Regulatory Affairs experience in the medical device industry, including hands-on authorship, review, or leadership of regulatory submissions such as 510(k)s, Technical Documentation/Technical Files, pre-submissions, international registrations, or related applications.\nMinimum 5 years of experience leading regulatory strategy for new product development, design changes, sustaining engineering, or product lifecycle management in a regulated medical device environment.\nMinimum 4 years of direct people-management experience, including hiring, performance management, talent development, coaching, and resource planning.\nPREFERRED REQUIREMENTS\nMaster’s degree or MBA preferred.\nRegulatory Affairs Certification (RAC) preferred.\nExperience managing regulatory professionals and/or managers across multiple portfolios, locations, or business units preferred.\nExperience interacting directly with FDA, Notified Bodies, Health Canada, and other global regulatory authorities preferred.\nStrong working knowledge of FDA medical device regulations, EU MDR, Health Canada, and other international regulatory frameworks.\nDemonstrated ability to lead regulatory strategy, manage competing priorities, identify approval risks, and develop practical mitigation plans.\nStrong written and verbal communication skills with the ability to communicate regulatory positions, submission strategy, and business impact to technical and executive audiences.\nDemonstrated sound judgment, decision-making capability, and ability to work independently in a fast-paced, regulated environment.\nExperience supporting audits, inspections, technical documentation, labeling review, design controls, risk management, and product lifecycle management preferred.\nProficiency with Microsoft Office, ERP systems, and regulatory information/document management systems preferred.\nDemonstrated ability to lead continuous improvement of regulatory processes, metrics, and inspection readiness preferred.\nPhysical Requirements\nAbility to sit and/or stand for extended periods during a standard workday and use a computer and standard office equipment.\nADA Disclosure: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nThis position is not eligible for employer-based sponsorship.\nDisclosure as required by applicable law, the annual salary range for this position is $138,700.00 - $215,100.00 USD Annual. The actual compensation may vary based on geographic location, work experience, education and skill level. The salary range is CONMED’s good faith belief at the time of this posting.\nBenefits:\nCONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.\nCompetitive compensation\nExcellent healthcare including medical, dental, vision and prescription coverage\nShort & long term disability plus life insurance -- cost paid fully by CONMED\nRetirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period\nEmployee Stock Purchase Plan -- allows stock purchases at discounted price\nTuition assistance for undergraduate and graduate level courses\nKnow someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!\nCONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply.The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.\nColorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.\nIf you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.","description_format":"text","description_chars":7336,"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":["401k plan","Life insurance","Retirement plans"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Surgical Instruments & Devices","Health & Medical Electronics"],"lifecycle":[{"event":"open","at":"2026-09-29T08:45:11Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 2 · green card filings: 1","filings_12m":2,"filings_prev_12m":2,"green_card_filings_12m":1,"median_offered_wage_usd":99167,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+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":23,"band":"cold","label":"Long shot","p_open":1,"p_active":0.66,"p_room":0.35,"age_days":57,"expected_fill_days":28,"reasons":["conf:0","velocity","win:tail"],"computed_at":"2026-11-05T05:54:30Z"},"pay":{"stated_usd_annual":215100,"is_top_pay":true},"html_url":"https://alion.io/job/conmed-senior-manager-regulatory-affairs","json_url":"https://alion.io/job/conmed-senior-manager-regulatory-affairs.json","meta":{"generated_at":"2026-11-06T04:00:20Z","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":6796,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-07T00:00:00Z"}},"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":1896673},"rest":"https://alion.io/mcp/rest/get_company?id=1896673"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fconmed-senior-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%2Fconmed-senior-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%2Fconmed-senior-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/conmed-senior-manager-regulatory-affairs\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fconmed-senior-manager-regulatory-affairs"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1453573}},{"tool":"search_jobs","arguments":{"company":"conmed.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1453573},"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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