{"id":1203633,"url":"https://alion.io/job/arthrex-director-regulatory-affairs-product-development","title":"Director, Regulatory Affairs (Product Development)","company":{"id":12664,"name":"Arthrex","domain":"arthrex.com","url":"https://alion.io/company/arthrex","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":{"grade":"A","score":100,"open_postings":10,"ghost_share":0,"stale_share":0.1,"repost_share":0,"time_to_fill_p50_days":20,"computed_at":"2026-10-20T05:45:00Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Naples, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":110000,"max_usd":212000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":307},"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-30T02:00:00Z","employer_posted_date":"2026-08-30","last_verified_at":"2026-10-20T08:22:16Z","board_verified":true,"closed_at":null,"days_open":51,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":51},"description":"Requisition ID:\n66263 \n\n Title:\nDirector, Regulatory Affairs (Product Development)\n\nJoin Arthrex and help shape the future of medical device innovation.\nWe are seeking an experienced Director, Regulatory Affairs (Product Development) for our global headquaters in Naples, FL.who will lead regulatory strategy and execution across our product development portfolio, including new product introductions, product modifications, and marketing material approvals. This high-impact leadership role partners closely with Engineering, Product Management, Clinical, Operations, and Quality teams to drive successful product commercialization and global regulatory compliance. At Arthrex, you'll work alongside industry-leading innovators dedicated to improving surgical outcomes worldwide. This is an opportunity to make a significant impact on the development and commercialization of cutting-edge medical technologies while leading a talented regulatory team in a collaborative, mission-driven environment.\nArthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™.\nEssential Duties and Responsibilities:\nLead regulatory oversight for new product development, product design and process modifications, and related engineering changes.\nLead a team of Regulatory Affairs people leaders who manage segment-aligned teams and provide regulatory support across the product development lifecycle across all business segments.\nServe as the senior regulatory partner to Engineering and Product Management, ensuring early alignment on regulatory strategy and risk mitigation during design and development.\nDrive integration of regulatory deliverables into design control documentation, technical files, and DHFs.\nGuide the preparation and strategic planning of regulatory submissions for the U.S. (510(k)), Canada (Medical Device Licenses), and the European Union (CE Marking under MDR).\nAlign regulatory approaches across business segments to ensure consistency in decision-making, risk tolerance, and execution practices.\nRepresent Regulatory Affairs in product development governance, program reviews, and cross-functional working groups.\nDirect the regulatory review and approval process for promotional and marketing materials related to new and modified products.\nSupport the review and refinement of labeling, instructions for use (IFUs), and promotional claims to ensure compliance with global regulatory standards.\nLead regulatory strategy for innovation-focused or high-risk programs in collaboration with internal and external stakeholders.\nSupport the development and performance of regulatory personnel, including leadership coaching and succession planning.\nContribute to inspection readiness, regulatory audits, and internal quality system improvement initiatives.\nEducation and Experience:\nBachelor’s Degree required; advanced degree preferred (MBA, MS) preferred.\n12+ years of experience in Regulatory Affairs with at least 5 years in a leadership role.\nDemonstrated success managing regulatory personnel and overseeing strategy for product development and change management programs.\nKnowledge and Skill Requirements/Specialized Courses and/or Training:\nIn-depth knowledge of FDA 510(k) and EU MDR regulatory pathways.\nExpertise in design control, engineering change processes, risk management, and product lifecycle documentation.\nStrong leadership, communication, and collaboration skills across cross-functional teams.\nAbility to translate complex regulatory concepts into actionable strategies for business and technical partners.\nAbility to plan, evaluate, and improve the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output.\nExperience in regulatory review of labeling and promotional materials in compliance with FDA, FTC, Health Canada, and EU advertising standards.\nBusiness Impact Statement:\nThis position plays a critical role in enabling product commercialization by ensuring timely regulatory approvals across the U.S., Canada, and EU. It directly supports revenue generation by protecting product launch timelines and ensuring compliance with evolving global regulatory requirements. The Sr. Director helps safeguard business continuity through regulatory risk mitigation and alignment with internal product development and market release goals.\nAutonomy & Decision-Making:\nThis role operates with significant autonomy in regulatory strategy development, submission planning, and execution oversight. The Sr. Director exercises independent judgment in determining regulatory pathways, assessing risk, managing design control readiness, and driving issue resolution. The individual is accountable for regulatory performance and readiness across multiple product families and global markets, and is empowered to represent the function in high-level cross-functional discussions and business planning.\n\nLanguage and Communication Skills:\nAbility to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.\nArthrex Benefits\nMedical, Dental and Vision Insurance\nCompany-Provided Life Insurance\nVoluntary Life Insurance\nFlexible Spending Account (FSA)\nSupplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)\nMatching 401(k) Retirement Plan\nAnnual Bonus\nWellness Incentive Program\nFree Onsite Medical Clinics\nFree Onsite Lunch\nTuition Reimbursement Program\nTrip of a Lifetime\nPaid Parental Leave\nPaid Time Off\nVolunteer PTO\nEmployee Assistance Provider (EAP)\nEligible for discretionary Long Term Incentive program\nAll qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.","description_format":"text","description_chars":6170,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":5,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["Life insurance","Parental leave","Retirement plans","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Orthopedic & Spine Implants"],"lifecycle":[{"event":"open","at":"2026-09-24T22:28:16Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 19 · green card filings: 2","filings_12m":19,"filings_prev_12m":27,"green_card_filings_12m":2,"median_offered_wage_usd":167500,"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":18,"band":"cold","label":"Long shot","p_open":1,"p_active":0.649,"p_room":0.28,"age_days":51,"expected_fill_days":20,"reasons":["conf:3","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-20T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/arthrex-director-regulatory-affairs-product-development","json_url":"https://alion.io/job/arthrex-director-regulatory-affairs-product-development.json","meta":{"generated_at":"2026-10-20T09:14:45Z","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":10087,"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":12664},"rest":"https://alion.io/mcp/rest/get_company?id=12664"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Farthrex-director-regulatory-affairs-product-development"},{"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%2Farthrex-director-regulatory-affairs-product-development"},{"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%2Farthrex-director-regulatory-affairs-product-development"},{"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/arthrex-director-regulatory-affairs-product-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Farthrex-director-regulatory-affairs-product-development"}]}