{"id":726190,"url":"https://alion.io/job/clinchoice-senior-associate-regulatory-affairs-2","title":"Senior Associate, Regulatory Affairs","company":{"id":672996,"name":"ClinChoice","domain":"clinchoice.com","url":"https://alion.io/company/clinchoice","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":78,"open_postings":13,"ghost_share":0,"stale_share":0.846,"repost_share":0.077,"time_to_fill_p50_days":39,"computed_at":"2026-10-29T05:49:05Z"}},"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":["Cincinnati, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":101000,"max_usd":176000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":356},"experience_years_min":1,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"ISO 13485","optional":false},{"name":"Microsoft Office","optional":true}],"status":"live","first_seen_at":"2026-08-05T17:29:27Z","employer_posted_date":"2026-09-03","last_verified_at":"2026-10-30T03:15:18Z","board_verified":true,"closed_at":null,"days_open":85,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":85},"description":"ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as aSenior Associate, Regulatory Affairs (ONSITE) on a permanent basis at Cincinnati, OH.\nJoin our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!\nJob Title: Senior Associate, Regulatory Affairs\nEmployment Type: Full Time\nLocation: Hybrid (Cincinnati, Ohio) - Location Address: 4545 Creek Rd Blue Ash, OH 45242\nResponsible for managing, planning, preparation, and delivery of documents both electronic- and paper-based in support of assigned. global regulatory product registrations, renewals, tenders/customs, etc.\nCoordinate the preparation and submission of medical device applications by providing regulatory information and documents and following up closely on queries from inspection through approval.\nPrepare and/or review letters of authorization, cover letters for registration certificates, declarations, power of attorney, and other regulatory documentation to ensure accuracy, appropriateness, and consistency of documents intended for various global regulatory submissions.\nSubmit and manage applications for the US FDA Certificates to Foreign Government (CFGs).\nMaintain various tracking tools to ensure up-to-date information and traceability of all regulatory data/documentation.\nPerform and/or coordinate legalization, notarization, and apostille of regulatory documents\nEnsure compliance with current good documentation practices, including but not limited to proofreading, formatting, indexing and recordkeeping.\nAssist all regions in answering inquiries and providing required documents and information utilizing various search tools and systems.\nPerform document filing and retrieval functions as directed and per company’s policies and procedures.\nEffectively communicate with internal and external teams and/or clients as to the status of deliverables, to ensure timely and satisfactory completion of tasks and expectations.\nCommunicate with the project teams on a regular basis regarding regulatory updates.\nProvide support to internal and external teams to address various technical inquiries and provide requested data/information\nParticipate in group meetings and provide tactical approaches to addressing issues of basic complexity\nPerform other tasks as assigned.\n\nExperience/Skills\n\nBachelor’s degree (Life Sciences or a regulatory related field preferred)\nMinimum of 1 year of hands-on experience in medical device regulatory affairs, or at least 3 years of combined regulatory affairs and related experience.\nBasic knowledge of US FDA QSR, ISO 13485, EU MDD/MDR.\nKnowledge of global medical devices registration process is a plus\nProficient in Microsoft Office (e.g., Word, Excel, PowerPoint)\nHave a good understanding of current Good Documentation Practices in a regulatory environment.\nSelf-starter with the ability to work in a team environment and on projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision.\nExcellent organizational skills with strong attention to detail, effective planning, and the ability to multitask efficiently\nMust possess excellent written and verbal communication skills.\nThe Application Process\nOnce you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.\nWho will you be working for?\nAbout ClinChoice\nClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. \nOur Company Ethos\nOur mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.\nClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. 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