- Medtronic (Los Angeles, CA)
- …compassionate world. **A Day in the Life** Position Overview: The Senior Manager , Field Corrective Actions is responsible for leading and managing all aspects ... a regulatory expert, interpreting and applying complex requirements from agencies (FDA, EU MDR, Health Canada, TGA, etc.), and guiding teams through evolving… more
- Medtronic (Lafayette, CO)
- …Care & Monitoring (ACM) group. The Principal Regulatory Affairs Specialist ( Pr . RAS) is responsible for collaborating, planning and executing regulatory activities ... Leads and compiles all materials required for US and EU submissions and tenders, including 510(k) submissions, NB sampling,...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Amazon (Hawthorne, CA)
- Description We are seeking an experienced Senior Product Launch Manager to join the Product Launch Management (PLM) team. In this role, you will lead go-to-market ... Brand and Product Marketing, In-store and Online Retail, Legal, PR , Customer Service, and Demand and Supply Planning. He/she/they...day in the life As a Senior Product Launch Manager , you will be managing multiple new product launches… more
- Kelly Services (Manati, PR)
- …you find a job that works for you. How about this one?** We're seeking for a Manager , Quality Assurance Scientist to work in the north region, in PR . With us, ... Dosage and Parenteral Products Manufacturing. + Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use.… more
- Kratos Defense & Security Solutions, Inc. (Herndon, VA)
- …and concepting, working with designers to develop meaningful infographics + PR experience #LI-Hybrid Competitive salary based on experience and education Kratos ... another employee or applicant. Job Applicant Privacy Notice For applicants in the EU and California residents, please review our privacy notice. From: Kratos Defense more
- Medtronic (Minneapolis, MN)
- …experience submitting regulatory submissions for both the Americas and the EU . **Role Overview** The Senior Regulatory Affairs Specialist develops strategies for ... approval for market release. + Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography… more
- Medtronic (Los Angeles, CA)
- …objectives. Understand current and upcoming Medical Device Reporting (MDRs) and EU Vigilance Reporting requirements by regulatory bodies and ensure adequate ... 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU , China & Japan regulations; ISO 13485, MDSAP, etc....with our team and the workplace environment. Your direct manager will be your point of contact to help… more
- Medtronic (Fridley, MN)
- …device industry experience. + Familiarity with these regulations: FDA 21 CFR Part 820, EU 217/745 ( EU MDR) + Familiarity with these standards: ISO 13485, ISO ... computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions...career and life stage. Salary ranges for US (excl. PR ) locations (USD):$52,800.00 - $79,200.00 This position is eligible… more
- Medtronic (Lafayette, CO)
- …the preparation, review, and submission of regulatory filings in the US and EU . Directly engage with regulatory bodies (eg, FDA, Notified Body) to negotiate ... in regulatory affairs (typically 10+ years) + Experience as a people manager managing large teams (typically 7+ years) within pharmaceuticals, biotechnology, medical… more
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