- Medtronic (Boston, MA)
- Principal Regulatory Affairs Specialist...EU regulatory requirements and partners with the international regulatory affairs group to ... - Surgical The Principal Regulatory Affairs Specialist will play a key role in launching...process + Provide business and product information to the international regulatory affairs team to… more
- 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 (Malvern, PA)
- ** Principal Regulatory Affairs Specialist- Software & Artificial Intelligence (US Hub Based)** The Principal Regulatory Affairs Specialist- SW & ... study protocols._ + _Where applicable, represent Philips in an international committee chartered to develop AI regulatory ...an international committee chartered to develop AI regulatory framework._ **You're** **the right fit if:** + You've… 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 (Wyomissing, PA)
- …or engineering field, or equivalent work experience. * 5+ years of Medical Device Regulatory Affairs experience, domestic and international . 3 years of ... Sr. Regulatory Affairs Specialist **Date:** May 28,...The SRA will assist in mentoring and development of Regulatory Specialists as part of the role. ** Principal… 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
- 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
- Merck (North Wales, PA)
- …product withdrawal. + Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of ... our organization's biologics product franchises in accordance with domestic and international regulations and guidance. The Principal Scientist is responsible… 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
- Abbott (Princeton, NJ)
- …committee (SRC) and managing collaborative study protocol versions with APOC and Principal Investigator(s). The Scientific Affairs Manager will also liaise with ... also have access to: + Career development with an international company where you can grow the career you...mothers, female executives, and scientists. **The Opportunity** Our Scientific Affairs Team has an opportunity for a Manager, Global… 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 (San Francisco, CA)
- …For further information, visit: Recognition of Foreign Qualifications | International Affairs Office (ed.gov). Additional Information Receiving Service ... (HIPAA), and conflict of interest. Maintains records according to applicable regulatory requirements. Provides advice on and answers questions about administrative… more