- Medtronic (Minneapolis, MN)
- …Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to ... regulatory filings to the FDA, EU MDR, and other global regulatory agencies. + **Knowledge of Regulatory Requirements:** In-depth understanding of… more
- 3M (Maplewood, MN)
- …discipline from an accredited institution + Experience working with high-risk applications, global customers, global regulatory bodies, and government ... new chemicals, materials, products, hard goods, technologies, and processes + Completing global , regulatory risk and compliance assessments for hardgoods. +… more
- Evident Scientific (Needham, MA)
- …of technical documentation, labeling, and registration activities. + Contribute to global regulatory strategy discussions, providing US compliance insights. ... Regulatory Compliance, leading end-to-end clinical programs and ensuring regulatory alignment with FDA and global standards....and ensuring regulatory alignment with FDA and global standards. The position serves as both a hands-on… more
- Teleflex (Wyomissing, PA)
- …* Basic experience working with cross-functional teams. Preferred: * Basic medical device global regulatory knowledge base (outside of the US, EU, and Canada): ... device listings, establishment registrations, inspections, audits, etc. * Support regulatory requests for global markets. * Update...audits, etc. * Support regulatory requests for global markets. * Update and maintain regulatory … more
- BD (Becton, Dickinson and Company) (Tempe, AZ)
- …Key Job Responsibilities (including supervisory and/or fiscal):** + Understands fundamental global regulatory requirements and different regulatory pathways. ... **Job Description Summary** The Regulatory Affairs (RA) Specialist will provide primary RA...regulatory strategies for marketing authorization for domestic and/or global markets. + Independently reviews product changes to ensure… more
- AbbVie (Irvine, CA)
- …(R&D) organizations. Represents RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, ... data and strategy to regulatory agencies. + Responds to global regulatory information requests. + Develops strategies for device agency meetings, manages… more
- Olympus Corporation of the Americas (Westborough, MA)
- …technologies and connected software systems. As needed provide input to define global regulatory strategy requirements. + Participate in teams for sustaining ... products to provide input on global regulatory requirements. + Support regulatory submissions, filings, and responses to regulatory or auditor inquiries… more
- Philips (Washington, DC)
- … Science & Policy Director is responsible for guiding the analysis of global regulatory requirements, policies and industry standards to identify their potential ... products and services. **Your role:** + Guides the analysis of global regulatory requirements and industry standards to identify their potential impacts on… more
- Philips (Bothell, WA)
- … Regulatory Compliance is responsible for formulating and executing comprehensive global regulatory strategies and roadmaps, ensuring alignment with Oral ... business objectives and competitive market analysis. **Your role:** + **Develop global regulatory strategies** by creating and implementing regulatory… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …to ensure the efficient operations of the function. **Primary Responsibilities:** + As Global Regulatory Lead, develops and oversees worldwide regulatory ... or new indication development. + Leads interactions and negotiates with global regulatory authorities regarding programs and initiatives that significantly… more