- Abbott (Santa Clara, CA)
- … requirements to software systems, including documentation, risk management, and compliance strategies. Assists management and leadership on regulatory ... regulatory skills to proposed strategies on complex issues + Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and update… more
- Takeda Pharmaceuticals (Boston, MA)
- …Therapeutic Area Unit (TAU) portfolio. This is accomplished through leadership of product -specific Global Regulatory Teams (GRTs) and representing the ... regulatory function on cross-functional Global Program Teams. The Senior Director also will lead discussions...global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies on product specific value… more
- Philips (Cambridge, MA)
- …recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and ... updates. **Your role:** + Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provides … more
- Emerson (Austin, TX)
- …+ Eight plus (8+) years of related work experience. + Focus on industrial product compliance with environmental regulatory requirements and a strong ... the Test & Measurement (T&M) business group (National Instruments) in collaboration with product compliance and engineering teams to mitigate risk and support… more
- Reynolds American (Winston Salem, NC)
- … product submissions, product integrity, clinical studies, and ongoing compliance with applicable state and federal regulatory requirements + Reviewing ... regular cross-functional meetings to provide advice and guidance regarding legal and regulatory compliance . + Regularly engaging and collaborating with global… more
- Amazon (Seattle, WA)
- …their existing solutions. * Collaborate with partner engineering teams to drive the product roadmaps for compliance and safety. * Address bottlenecks, provide ... with the tools and information they need to maintain compliance with mandated regulatory requirements and adherence...and external regulations. Basic Qualifications - 5+ years of product or program management, product … more
- Takeda Pharmaceuticals (Boston, MA)
- …support for assigned programs. + Partnering with the program Global Regulatory Lead (GRL), co-lead and facilitate product -specific Global Regulatory ... Management leadership, oversight, direction and planning. + Directly supports program GRL by ensuring project management and regulatory...submissions. + Partner with the GRL to ensure Global Product Team (GPT) regulatory goals are cascaded… more
- Medtronic (Mounds View, MN)
- …with device reviewers through oral and written communications. + Support regulatory compliance activities, including internal or external audits, post-market ... collaboration as we work together to engineer the extraordinary. The ** Regulatory Affairs Specialist** is responsible for developing regulatory strategies,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …from various partners. + Handle the development of custom reports to support regulatory compliance and advise strategy. + Collaborate with partners to support ... organization. * Provide analysis, advice, and guidance on US regulatory strategies to promote expedited product development...any compliance and process initiatives. + Own the review and… more
- Gilead Sciences, Inc. (Washington, DC)
- … regulatory initiatives focused on combination products and devices. Ensure regulatory conformance and consistency across markets, maintaining compliance with ... as well as serve as a liaison across other regulatory functions. . ** Program Oversight & Governance**...scope, as teams are working earlier on TPPs and product strategies. . ** Regulatory Operations & Submissions**… more
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