Global Regulatory Affairs PM - Medical Devices (Hybrid)
Roche
Roche in Indianapolis is seeking an experienced regulatory affairs professional to register and support regulatory activities for in vitro diagnostic products across global markets. You will collaborate with researchers, clinicians, and manufacturing teams to ensure compliance and timely submissions, including CE, PMA, 510(k), and other regulatory filings, while leveraging RPA where appropriate. This hybrid role requires a Bachelor's or Master's in Life Science or related field and about 5 years #J-18808-Ljbffr Roche
- Nanosonics, a global developer of innovative reprocessing solutions for reusable medical devices, seeks a Director of Information Technology Services - Americas. This hybrid role requires residence in the greater... ...cybersecurity, quality, regulatory and business teams to...Medical device
$135k - $190k
...innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory. It’s all part of our... ..., pricing, or commercial excellence within life sciences, medical devices, diagnostics, or adjacent regulated industries.Proven experience...Medical deviceFull timeContract workPart timeRemote workWork from homeFlexible hours$93k - $172.9k
...wide array of innovative medical diagnostic products... ...activities associated with regulatory approval of in vitro diagnostic medical devices in global markets Provide... ...development, clinical affairs, quality, or program management... ...or Tucson. This is a hybrid role; remote work...Medical deviceLocal areaRemote workRelocation package- Elanco, a global leader in animal health, seeks a Senior Counsel, Global Trade to guide U.S. and international trade compliance across... ...supply chain and financing contexts. Location in Indianapolis with hybrid work, requiring 5-10 years of international trade experience and...Suggested
$84.6k - $157.2k
...love. That’s what makes us Roche. As a Regulatory Affairs Project Manager you will have the... ...understanding of complexities and challenges in a global regulatory environment.You hold strong... ...Healthcare Regulatory Affairs for IVD/Medical Device preferred.You can manage high...Medical deviceFull timeLive inLocal areaRelocation packageShift work- ...ensuring alignment with the organization\'s global quality objectives. The ideal candidate... ...within life sciences, pharmaceutical, medical device, or other highly regulated industries,... ...Details: Schedule: Full-time Work Setup: Hybrid (2-3 days onsite per week) in Indianapolis...Medical deviceFull timeContract work2 days per week3 days per week
$111.2k - $258.7k
...unassailable ethics, and access to medical innovations for all. We do... ...of the Medical Value Assays Regulatory Affairs Leadership Team (MVA RALT).... ...objectives. You monitor the global regulatory environments, and... ..., and /or Medical Device industry; Regulatory Compliance...Medical deviceFull timeLocal areaRelocation package- Roche seeks a Global Product Launch and Supply Chain Lead to drive organization-wide integration for instruments across international... ...thinking. With 8+ years of leadership in diagnostics or medical devices, you will guide complex hardware launches in regulated environments...Medical device
- ..., batch review, final release, nonconforming materials, and QA documentation, with audits and cross-functional collaboration. This hybrid role requires in-depth knowledge of QC processes, eQMS workflows, CAPA, materials control, labeling and UDI, and supervision as the...Medical device
- ...reporting materials as needed. Partner with Global Finance and Accounting to ensure... ...Experience in pharmaceutical, biotechnology, medical device, or other highly regulated industries... ...'s next in precision medicine. We have hybrid and remote employees located all around...Medical deviceContract workRemote work
- Jobot seeks an International Tax Manager for a hybrid role in Indianapolis. You will develop and optimize international tax strategies, ensuring compliance across jurisdictions and supporting complex multinational structures. The role covers planning for mergers, acquisitions...
$177k - $308k
...around the world. We are a global healthcare leader... ...ensuring scientific rigor, regulatory defensibility, and... ..., Regulatory Affairs) to ensure seamless AI... ...Indianapolis, IN or Boston, MA (hybrid work model available)... ...; eligibility for medical, dental, vision and prescription...Flexible hours- ...the pharmaceutical, biotech, and medical device industries with our proven, scientific... ...to complex trial data and regulatory submission challenges. With a global footprint across four continents,... ...paper CRF study systems, EDC, and hybrid CDM systems Extensive knowledge of...Medical deviceRemote work
- ...management reports for capitation initiatives. The role supports training actuarial staff and may coordinate special projects, with a hybrid in-office schedule 1-2 days per week to balance collaboration and remote work. #J-18808-Ljbffr JIT Global Freight Solution P LtdWork at officeRemote work2 days per week1 day per week
$72k - $84k
...Here is what we offer Flexible hybrid workforce model: Onsite three... ...! Awesome Benefits Package: Medical, dental, vision benefits and... ...sources, such as S&P Global Market Intelligence, Bloomberg... ...compliance with and monitor regulatory requirements and Bank policies...Full timeSummer workWork at officeRemote workFlexible hours3 days per week- ...meeting the demands of patient safety, regulatory compliance, and an evolving global supply network. How do we do it?... ...that integrate commercial, medical affairs, regulatory, quality, and operations... ...industries: Biopharma, Medical Devices / Med Tech, CDMO/CMO, or adjacent...Medical deviceFull timeWork experience placementLive inWork at officeLocal area
$20 - $23 per hour
...Medical Device AssemblerCome create your career with Volt. Volt is immediately hiring a Medical Device Assembler in Westfield, IN 46074. As... ...time, contract opportunity.Schedule: 1st Shift: 6:00 AM to 2:30 PM Monday to Friday2nd Shift: 2:30 PM to 11:00 PM Monday to FridayThe...Medical deviceHourly payFull timeContract workTemporary workImmediate startShift workDay shift- Roche Diagnostics seeks a senior Regulatory Affairs leader to coach and guide a team of 10-15 staff, acting as SME with US FDA and international... ...related fields, with knowledge of IVD, pharmaceutical, or medical devices, plus strong communication and #J-18808-Ljbffr F....Medical device
- At Elanco (NYSE: ELAN) - it all starts with animals!As a global leader in animal health, we are dedicated to innovation and delivering... ...- 15%Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work EnvironmentDon't meet every single requirement? Studies have...Full timeSummer workRelocationFlexible hours
- Lilly in Indianapolis, IN is seeking a Global Regulatory Lead (GRL) to drive global regulatory strategies from entry through end of life. You... ...an advanced scientific degree with 8+ years in regulatory affairs or a bachelor’s/masters with 10+ years. Travel ~10-15% is anticipated...
$169.5k - $248.6k
...join us. About the RoleAs the Global Regulatory Lead (GRL), you will be the... ...scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global LabelingFoster... ...of experience in regulatory affairs and/or drug... ...vacation benefits; eligibility for medical, dental, vision and prescription...Local areaFlexible hours- ...technology.Barry-Wehmiller is a diversified global supplier of engineering consulting and... ...difficult problems. You will join our Regulatory Compliance Practice and partner with... ...project experience in the pharmaceutical or medical device environmentsStrong technical writing...Medical deviceFull timeWork at officeFlexible hours
- ...Location: Indianapolis, IN 46256 Shift: Hybrid - 3days oniste and 2days offsite... ...experience in a similar role within the medical device sector. Knowledge of deviation and resolution... ...and experience interacting with global internal and external partners and suppliers...Medical deviceContract workShift work
- Initial Therapeutics, Inc. seeks a Global Regulatory Lead in Indianapolis, IN. The role involves developing regulatory strategies, overseeing... ...scientific degree and substantial experience in regulatory affairs or drug development. This position demands strong leadership...Relocation package
- ...its Empowered Official and primary export control contact for the Global Trade team. You will design, implement, and maintain Salesforce'... ...function, reporting to the Head of Global Trade. This is a hybrid role with three days in the Salesforce office each week. #J-188...Work at office
$163.4k - $322.1k
...leadership The Team An evolving customer and regulatory landscape, mounting pipeline of next-... ...solutions, both domestically and globally. We are looking for practitioners who will... ...firms to global big pharma to medical device companies, to drive business value through...Medical deviceLocal areaFlexible hours$198.7k - $391.6k
...trends The Team An evolving customer and regulatory landscape, mounting pipeline of next-... ...solutions, both domestically and globally. We are looking for practitioners who will... ...biotechnology firms to global big pharma to medical device companies—to drive business value...Medical deviceLocal area- A global insurance provider is looking for a Compliance Analyst to ensure compliance with regulatory guidelines for their insurance products. This role involves monitoring legal changes... ...a competitive salary, benefits, and a hybrid work model, focusing on fostering a...
- ...Indianapolis is seeking a full-time temporary Document Control Coordinator to support the document control team. This hybrid position involves interacting with global stakeholders, ensuring compliance with company standards, and maintaining confidentiality of sensitive...Full timeTemporary workWork at office
- ...supporting Design History File (DHF) activities for medical device development projects, ensuring compliance with regulatory and quality system requirements. The engineer... ...projects. Review, update, and maintain Global dFMEA documentation, ensuring risks are adequately...Medical deviceFull time
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