{"id":1645164,"url":"https://alion.io/job/organogenesis-program-manager-regulatory-affairs","title":"Program Manager, Regulatory Affairs","company":{"id":2649947,"name":"Organogenesis","domain":"organogenesis.com","url":"https://alion.io/company/organogenesis","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Schema","truth_index":null},"role":"Management","role_family":"Management","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":["Canton, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":119000,"max":140000,"currency":"USD","period":"year","gross":null,"usd_annual":140000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-30T00:00:00Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-04T01:21:22Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. We offer a strong benefits package, opportunities for growth, and the chance to contribute to our mission: to provide an integrated portfolio of healing solutions that improve lives while lowering the overall cost of health care.\nWhat You Will Achieve:\nIn this role, you will be primarily responsible for handling regulatory affairs requirements for medical devices and biologic products, including Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). You will develop regulatory strategies and regulatory submissions for new and modified products to the FDA and International regulatory bodies. This individual will also provide regulatory support and guidance for product changes to US marketed products.\nHow You Will Achieve It:\nWorking closely with process development, manufacturing and quality departments to support the preparation of domestic and international regulatory submissions. This includes writing, reviewing, and editing technical reports and regulatory documentation.\nProviding input on and review of protocols and reports including but not limited to process validation, equipment qualification, and shelf-life studies.\nEnsuring regulatory compliance with QSR and cGMP requirements and stay apprised of ICH, FDA and EU requirements.\nEvaluating changes to determine the filing requirements and impact on AATB certifications, state licenses, and FDA registrations. \nReview of labeling changes, and advertising and promotional material. \nReview of complaints for medical device reporting (MDR) requirements.\nReview of events related to potential biologic deviation reporting (BPDR).\nRequirements\nWhat you need to achieve:\nBS degree is required with a degree in science, technology, engineering, or mathematics. Advanced degree and/or regulatory credentials (i.e., MS, RAC) is preferred.\nA minimum of 5 years of relevant regulatory affairs experience in the biotech industry required; a minimum of 3 years of experience in developing regulatory strategies, planning and preparing regulatory submissions required.\nExperience with regulatory product lifecycle management required.\nRegulatory experience with development of Medical Device and Biologic products required, including working knowledge in the submission of regulatory filings for device and/or biologic products; experience with PMA, IND, BLA and/or 510(k).\nMust have a good working knowledge of relevant regulations and industry standards. Strong organizational, interpersonal and written/verbal communication skills required.\nExperience with technical aspects of product development and manufacturing.\nOther Skills/Abilities:\nWorking knowledge of FDA and International Biologics/Drug/Device regulations is preferred. \nIn addition, prior experience with medical device and biologic development and registrations is a plus.\nAbility to prioritize and multi-task projects independently is preferred. \nStrong organizational, interpersonal and written/verbal communication skills are required.\nAbility to lead meetings by preparing and presenting regulatory strategies and requirements is required. \nWhat can we offer you?\n401k -- generous employer match with immediate vesting and financial planning resources\nComprehensive Medical, Dental and Vision coverage options effective on day one of employment\nFlexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account\nCompany paid insurances including Short Term, Long Term and Life insurances as well as voluntary options\nPaid maternity leave and parental leave for all new parents\nAdoption benefits\nEducation Assistance Policy - $5,000 per year for all employees\nWellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more\nEmployee Assistance Program\nGenerous paid time off including vacation, floating holidays, sick days, and company holidays\nFree parking including an electric charging station (Canton and La Jolla)\nDiscounts at BJs Wholesale, Dell, Sullivan Tire\nThe anticipated annualized base salary is $119,000 - $140,000 and reflects current market data for similarly-sized life science companies and internal equity. Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law.\nWe are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law.\nWe do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes.","description_format":"text","description_chars":5545,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Education assistance","Equity","Life insurance","Parental leave"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Sports Medicine"],"lifecycle":[{"event":"open","at":"2026-10-01T23:21:57Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1 · green card filings: 2","filings_12m":1,"filings_prev_12m":3,"green_card_filings_12m":2,"median_offered_wage_usd":89167,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+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":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":3,"expected_fill_days":25,"reasons":["conf:0","win:early"],"computed_at":"2026-10-03T05:45:00Z"},"pay":{"stated_usd_annual":140000,"is_top_pay":false},"html_url":"https://alion.io/job/organogenesis-program-manager-regulatory-affairs","json_url":"https://alion.io/job/organogenesis-program-manager-regulatory-affairs.json","meta":{"generated_at":"2026-10-04T02:26:00Z","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":3478,"day_limit":5000,"remaining_today":1522,"minute_limit":60,"resets_at":"2026-10-05T00:00:00Z"}}}