- Medtronic (Mounds View, MN)
- PRINCIPAL REGULATORY AFFAIRS SPECIALIST - CARDIAC SURGERY (Hybrid) Cardiac surgery represents end stage treatment in the care continuum for many ... medical technology and solutions Careers that Change Lives The Principal Regulatory Affairs Specialist is...for existing approved products. + Team with business unit Regulatory Affairs Specialists (RAS) and international… more
- Abbott (Pleasanton, CA)
- …working mothers, female executives, and scientists **The Opportunity** We are seeking a ** Principal Regulatory Affairs Specialist** to join Abbott's Heart ... in Pleasanton, CA. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is...Prepares robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental and… more
- Abbott (Atlanta, GA)
- …working mothers, female executives, and scientists **The Opportunity** We are seeking a ** Principal Regulatory Affairs Specialist** to join Abbott's Heart ... Failure Division. As an individual contributor, the Principal Regulatory Affairs Specialist is...Complies with US Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies,… more
- Medtronic (Northridge, CA)
- …with 90,000+ employees in more than 160 countries. **A Day in the Life** As Principal Regulatory Affairs Specialist, you will develop and implement medical ... regulatory agencies. + As an individual contributor, the Principal Regulatory Affairs Specialist is... requirements for US, EU (EU MDR), and other international geographies. + Experience with medical device software requirements… more
- Philips (Pittsburgh, PA)
- ** Principal Regulatory Affairs Specialist, Software (US Hub based)** Clinical Integration and Insight (CII) is changing the way healthcare is delivered at ... (CII) business unit._ + _Lead project teams for end-to-end Regulatory Affairs input and deliverables for new...business, and the local RA teams in the Philips international markets organization._ + _Build regulatory submissions… more
- HRPivot (Tucson, AZ)
- …us at www.syncardia.com. Position description: SynCardia is looking for an energetic International Regulatory Affairs Manager. The successful candidate will ... tasks will include planning, preparing, managing, monitoring, and budgeting the Company's international regulatory affairs projects: coordinating and working… more
- Fresenius Medical Center (Waltham, MA)
- …issues and broad design matters. + Understands and interprets US and international medical device regulatory requirements, provides guidance on requirements to ... This position can be fully remote. **PURPOSE AND SCOPE:** Develops regulatory strategies for assigned products/product lines. Prepares regulatory submissions… more
- Teleflex (Maple Grove, MN)
- Sr. Regulatory Affairs Specialist **Date:** May 12, 2024 **Location:** Maple Grove, MN, US **Company:** Teleflex **Expected Travel** : None **Requisition ID** ... solutions that make a difference in patients' lives. **Position Summary** The Regulatory Affairs Specialist will develop strategies and submissions for projects… more
- Colgate-Palmolive (Topeka, KS)
- …and foster a climate of teamwork and effective working relationships both within Regulatory Affairs and with our internal business partners: Quality, Marketing, ... will also have responsibility for managing and developing internal regulatory staff. ** Principal responsibilities:** Regulatory ...Animal/Food Sciences, or equivalent; + Minimum 5 years in Regulatory Affairs within any of the following… more
- Tecomet (Kenosha, WI)
- **Sr. Quality and Regulatory Affairs Manager** **Build innovative solutions and design the future** . You can pursue your potential at Tecomet by working with a ... provide overall company leadership and direction for Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities.… more
- Fresenius Medical Center (Waltham, MA)
- …for marketed products, labels and clinical materials for products in development. ** PRINCIPAL DUTIES AND RESPONSIBILITIES:** + Provides regulatory assessment and ... can be fully remote. **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …for the clinical research aspects of registration activities with a working knowledge of regulatory affairs , in the development of the project strategy and the ... Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device… more
- Teleflex (Hartford, CT)
- …(QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which Teleflex complies. **Language and ... to the Sr. Managers and can be delegated to the assigned Clinical Affairs Managers should this action be necessary. ** Principal Responsibilities** + Manage… more
- Invenergy (Washington, DC)
- …+ Collaborate with Invenergy's origination, development, procurement, finance, state government affairs , environmental and regulatory affairs teams for ... jobs. Invenergy has a broad portfolio of domestic and international business interests and advocates across technologies such as...Affairs team, for Invenergy's executive team. + Arrange principal - level meetings for Invenergy leaders and ,… more
- Teleflex (Morrisville, NC)
- Clinical Affairs Manager **Date:** May 23, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 50% **Requisition ID** :10398 ... that make a difference in patients' lives. **Position Summary** The Clinical Affairs Manager provides clinical expertise, insight and support to clinical end-users,… more
- Teleflex (Morrisville, NC)
- Clinical Affairs Manager - Interventional **Date:** May 21, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 50% ... that make a difference in patients' lives. **Position Summary** The Clinical Affairs Manager provides clinical expertise, insight and support to clinical end-users,… more
- Veterans Affairs, Veterans Health Administration (IN)
- …services. Selects and assigns codes from the current versions of the International Classification of Diseases (ICD) Clinical Modification (CM) and Procedure Coding ... Equitable Resource Allocation (VERA) program. Maintains current knowledge of regulatory and policy requirements affecting coded information. Reviews health record… more
- Abbott (Santa Clara, CA)
- …other departments including Global Clinical Operations, Research & Development (R&D), Regulatory Affairs , Safety and Biostatistics. + Writes study protocols, ... regulatory agency meetings. + Works collaboratively with R&D, Clinical R&D, Regulatory Affairs , Library Services, Product Performance Group (PPG), Quality… more
- Microsoft Corporation (Washington, DC)
- …Microsoft's Global Trade Legal and Policy team advances this mission through international trade policies, strategies and solutions that foster a culture of ... and innovation across Microsoft and with our partners and customers worldwide. This Principal Corporate Counsel - Export Controls and Sanctions, Policy role is an… more
- Abbott (St. Paul, MN)
- …and exchange of documents between stakeholders (eg, internal personnel such as Regulatory Affairs , Product Performance Group (PPG), Sales and Marketing, Quality ... of changes in Medical Writing per EU and Canada regulatory guidelines. The Principal Medical Writer will... regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. +… more