{"id":1695202,"url":"https://alion.io/job/deka-research-development-regulatory-affairs-project-manager-deka-research-development","title":"Regulatory Affairs Project Manager - DEKA Research & Development","company":{"id":2016025,"name":"DEKA Research & Development","domain":"dekaresearch.com","url":"https://alion.io/company/dekaresearch","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"JazzHR","truth_index":null},"role":"Management","role_family":"Management","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Manchester, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":89000,"max_usd":167000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":3691},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-02T12:01:51Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-10-12T17:47:43Z","board_verified":true,"closed_at":null,"days_open":11,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":11},"description":"DEKA Research & Development has an immediate opening for a Regulatory Affairs Project Manager to contribute to a dynamic, medical device research and development environment. The individual in this high visibility role will have a significant and direct impact on the success of the innovative life science devices that DEKA develops. The person in this role will formulate and execute regulatory strategies to deliver FDA approval or clearance as well as international approvals including CE Marking.\nHow you will make a difference as a Regulatory Project Manager:\nWork in close association with customers and development teams to define and execute regulatory approval and clearance programs, including establishing regulatory requirements and leading the preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, and other international dossiers\nProvide leadership and guidance to R&D in developing successful regulatory strategies across the entire product life cycle\nMentor regulatory affairs staff, as well as internal cross-functional partners, on effective regulatory strategies and tactics\nLead FDA interactions including in-person meetings, teleconferences, written submissions and other Agency engagements as needed\nParticipate in the design and conduct of clinical trials, and assist in obtaining and maintaining the appropriate regulatory approvals from the FDA, IRBs and/or Ethics Boards\nContinually improve internal regulatory processes and procedures to increase efficiency and reduce time to market while maintaining the highest levels of compliance\n Skills you will need to be successful:BS in a technically related field\nMinimum of 5 years direct work experience in a medical device, drug or biologic regulatory role with demonstrated success in obtaining product approvals/clearances\nExperience in direct FDA interactions including premarket notifications, IDE’s, Q-submissions and participation in face-to-face meetings\nStrong written and verbal communication skills\nDemonstrated ability to continually balance priorities in a dynamic and fast-paced environment\nExpertise in current FDA processes including the eSTAR submission tool, establishment registration and listing, UDI, product labeling, and post-market reporting including MDR’s and Field Action Reporting\nExperience in Medical Device Quality Regulations including Quality Management Systems Regulations (QMSRs), ISO 13485, and MDSAP\nDemonstrated ability in expanding regulatory organization capabilities\nExperience with drug, biologic and combination product approvals a plus\nRAC certification a plus\nAbout DEKA:\nOne hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.\nBehind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.","description_format":"text","description_chars":3174,"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":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-02T12:01:51Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 12 · green card filings: 1","filings_12m":12,"filings_prev_12m":14,"green_card_filings_12m":1,"median_offered_wage_usd":110962,"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":0.864,"p_room":1,"age_days":10,"expected_fill_days":37,"reasons":["conf:11","velocity","win:early"],"computed_at":"2026-10-13T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/deka-research-development-regulatory-affairs-project-manager-deka-research-development","json_url":"https://alion.io/job/deka-research-development-regulatory-affairs-project-manager-deka-research-development.json","meta":{"generated_at":"2026-10-13T18:08:14Z","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":27702,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-14T00:00:00Z"}},"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":2016025},"rest":"https://alion.io/mcp/rest/get_company?id=2016025"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fdeka-research-development-regulatory-affairs-project-manager-deka-research-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%2Fdeka-research-development-regulatory-affairs-project-manager-deka-research-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%2Fdeka-research-development-regulatory-affairs-project-manager-deka-research-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/deka-research-development-regulatory-affairs-project-manager-deka-research-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fdeka-research-development-regulatory-affairs-project-manager-deka-research-development"}]}