• Lundbeck (Deerfield, IL)
    …open to candidates in the greater United States** **SUMMARY:** The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the ... and development products/programs. + Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling requirements (CMC,… more
    DirectEmployers Association (12/04/25)
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  • CSL Behring (King Of Prussia, PA)
    …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... regulatory activities/submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience in working… more
    DirectEmployers Association (11/01/25)
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  • Olympus Corporation of the Americas (Westborough, MA)
    …subject matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the Olympus SDLC, ... projects as required by the SDLC and will support Regulatory Affairs ' efforts in creating submission materials...+ Minimum of 6 years of experience in a medical device setting. + Experience in the… more
    DirectEmployers Association (01/06/26)
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  • Olympus Corporation of the Americas (Center Valley, PA)
    … & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health Care ... years Medical Safety or Risk Management Experience ( Medical Device preferred to Pharma). + Extended...local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs… more
    DirectEmployers Association (12/05/25)
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  • Olympus Corporation of the Americas (Westborough, MA)
    …life sciences or related field. + Minimum of 8 years medical device industry experience post-degree preferably in Clinical Affairs /Operations, Medical ... and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs , and investigational sites. + Ensures...or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs… more
    DirectEmployers Association (12/11/25)
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  • Olympus Corporation of the Americas (Center Valley, PA)
    …+ Interpret statistical results; collaborate with cross-functional teams (clinical operations, regulatory affairs , medical writing, data management) to ... Data Management and Systems collaborating closely with MCA - Medical Affairs and Clinical Affairs ...is required. + Minimum of 6 years previous in pharmaceutical/ medical device industries or health care services… more
    DirectEmployers Association (12/05/25)
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  • Olympus Corporation of the Americas (Center Valley, PA)
    … products to ensure products meet current Good Manufacturing Practices, applicable medical device regulatory requirements, and for supporting business ... Duties** + Supports supplier quality activities for sourced finished Medical Device products and leads these supplier...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
    DirectEmployers Association (10/30/25)
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  • Olympus Corporation of the Americas (Westborough, MA)
    …industry experience post-degree preferably in Clinical Research, Clinical Development or Medical Affairs within the medical device industry. + Minimum of ... + Strong cross-functional collaboration experience, including working with Legal, Compliance, Regulatory , Medical Affairs , and Clinical Operations. +… more
    DirectEmployers Association (11/26/25)
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  • Olympus Corporation of the Americas (Center Valley, PA)
    …of 6 years of experience. + Prior experience in a sponsor, CRO, or medical device company. In-depth knowledge and experience with FDA regulations and familiarity ... and GCDMP. + Strong expertise in implementing and maintaining systems for global medical device trials (Class II/III or combination products). + Excellent… more
    DirectEmployers Association (10/28/25)
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  • Caris Life Sciences (Tempe, AZ)
    …Scientist will also serve as a liaison between Product Development and Quality Assurance/ Regulatory Affairs to ensure the product development process aligns with ... including design inputs, outputs and traceability. + Collaborate with Regulatory Affairs to prepare and review ...Control and product development within a regulated (IVD or medical device ) environment. + Ability to work… more
    DirectEmployers Association (12/20/25)
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