{"id":1192620,"url":"https://alion.io/job/dentsplysirona-regulatory-affairs-manager-oas","title":"Regulatory Affairs Manager, OAS","company":{"id":705415,"name":"Dentsply Sirona","domain":"dentsplysirona.com","url":"https://alion.io/company/dentsplysirona","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Public Policy","role_family":"Public Policy","seniority":null,"employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Sarasota, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":154000,"max":165000,"currency":"USD","period":"year","gross":null,"usd_annual":165000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":true}],"status":"live","first_seen_at":"2026-09-22T00:00:00Z","employer_posted_date":"2026-09-22","last_verified_at":"2026-09-24T22:14:47Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.\nBringing out the best in people\nAs advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us.\nWorking at Dentsply Sirona you are able to:\nDevelop faster - with our commitment to the best professional development.\nPerform better - as part of a high-performance, empowering culture.\nShape an industry - with a market leader that continues to drive innovation.\nMake a difference -by helping improve oral health worldwide.\n\nJob Summary:\nThe primary job responsibility for of the Regulatory Affairs Manager is overseeing the day-to-day functions of the Dentsply Sirona Orthodontics RA team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and providing guidance to their direct reports and cross-functional product development teams on Canada, EU and US regulatory requirements.\nThis role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.\nKey Responsibilities:\nDevelops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally.\nLeads and manages regulatory submissions, including 510(k) submissions, licensing in Canada, and technical files for CE marking.\nManages communications with FDA, Health Canada and EU notified bodies on behalf of the company for submission related discussions.\nProvides regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance documents to ensure compliance.\nCoordinates regulatory activities with internal teams and external regulatory agencies.\nReviews and approves product labelling and claims for the Canada, US and EU markets.\nStays current with regulatory requirements and updates affected policies and procedures.\nFosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships.\nManages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.\nComplies with company and departmental policies and administrative requirements.\nPerforms other duties as assigned or as needed.\nEducation:\nBachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.\nRegulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Master’s degree in a scientific discipline is a plus.\nYears and Type of Experience:\n5(+) years of experience in regulatory affairs, preferably in the medical device industry.\nExperience with leading regulatory submissions and managing regulatory projects.\nIn-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, MDSAP, EU MDR).\nExperience with software as a medical device, AI and/or medical devices containing software.\nPrior people management experience.\nRequired Computer / Software Skills:\nProficiency with Microsoft Office Suite\nProficiency with Regulatory software\nKey Required Skills, Knowledge, and Capabilities:\nStrong leadership, project management, and organizational skills including attention to detail.\nStrong written and verbal communication skills.\nPrior technical writing experience and proven track record with Canada, US and EU regulatory submissions.\nExcellent interpersonal skills.\nAbility to work effectively in a team environment and independently.\nKnowledge of regulatory affairs principles and practices.\nAbility to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported.\nWillingness to learn and adapt to new processes and technologies.\nLeadership experience within medical device organizations.\nKey Leadership Behaviors:\nActively articulates and promotes Dentsply Sirona’s vision and direction.\nAdvocates on behalf of the customer.\nValues driven with an insistence on excellence.\nPromotes high performance, innovation, and continual improvement.\nConsistently meets Company standards, ethics, and compliance requirements.\nStrong results orientation and analytical skills.\nClear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise.\nResolves conflicts and fosters a positive working environment.\nThe base salary and target annual incentive for this remote role is between $154,000 - $165,000. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.\nThis position is a hybrid working arrangement, working 4 days on-site and one remotely. This role can be filled at one of the following Dentsply Sirona locations:\nCalexico, CA\nCharlotte, NC\nJohnson City, TN\nLancaster, PA\nLas Piedras, Puerto Rico\nMilford, DE\nRichardson, TX\nSarasota, FL\nYork, PA\n\nDentsply Sirona is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.\nIf you need assistance with completing the online application due to a disability, please send an accommodation request to . Please be sure to include “Accommodation Request” in the subject.\nFor California Residents:\nWe may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes).\nThe above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity).\nFor additional details and questions, contact us at ","description_format":"text","description_chars":8234,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["Hybrid work","Professional development"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Medical Imaging Systems","Dental Products & Labs"],"lifecycle":[{"event":"open","at":"2026-09-24T17:24:21Z"}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":3,"expected_fill_days":27,"reasons":["conf:7","win:early"],"computed_at":"2026-09-25T05:45:01Z"},"pay":{"stated_usd_annual":165000,"is_top_pay":false},"html_url":"https://alion.io/job/dentsplysirona-regulatory-affairs-manager-oas","json_url":"https://alion.io/job/dentsplysirona-regulatory-affairs-manager-oas.json","meta":{"generated_at":"2026-09-26T04:26:56Z","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":4815,"day_limit":5000,"remaining_today":185,"minute_limit":60,"resets_at":"2026-09-27T00:00:00Z"}}}