- Abbott (Waukegan, IL)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** As a ** Global Standards Programs Manager ** , you will be the Subject ... strategic experience data management and data collection, particularly regarding emerging global regulatoryI database submission requirements. + **Leadership and… more
- Stryker (Fremont, CA)
- …study reports, regulatory-required routine reports, publications, podium clinical presentations, MDR -specific deliverables, CER/CES, etc. to the Global NV ... few. + All processes related to CER/CES generation for MDR , NMPA and other global regulators requiring...of all mandatory training and quality obligations with HR Manager . Creates training plans and tracks completion of mandatory… more
- Olympus Corporation of the Americas (Westborough, MA)
- …implementation of Global Customer Quality initiatives and programs throughout the Global organization, as required. + Site MDR /Regulatory Body Contact. + ... and authoring all worldwide additional information request responses prior to submission to corporate leadership and/or regulatory agencies. This position will… more
- Medtronic (Lafayette, CO)
- …approve design control documentation, regulatory change assessments, author regulatory documents ( MDR Technical Documents, STEDs or 510ks) and supporting EU MDR ... biotech or pharmaceutical industry **Nice to Have** + Knowledge of FDA and EU MDR requirements + Experience of working with all classification of product in the US… more
- Teleflex (MA)
- Sr. Regulatory Affairs Manager - Product Management **Date:** Oct 25, 2024 **Location:** Remote, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% ... **Requisition ID** :11022 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and… more
- Abbott (St. Paul, MN)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... more than 160 countries. **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people's...**The Opportunity** We are recruiting for a **Regulatory Affairs Manager ** to join our team in St. Paul, MN.… more
- Envista Holdings Corporation (Pomona, CA)
- **Job Description:** Under the direction of the Senior QA Manager , this position is responsible for ensuring that core functions of Quality Assurance are ... This involves assuring quality standards (FDA, ISO, CMDCAS, MDD, MDR , MDSAP and Canadian Medical Device requirements) are with...throughout the facility. + Responsible for the evaluation and submission of Medical Device Reporting to FDA and all… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** As Manager of RA you will be responsible for is establishing processes, strategies, and assessing business needs in the second largest ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...of EMEA regulatory bodies. + Act as RA EU MDR lead for Surgery RA and provide strategic direction… more
- Abbott (Alameda, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... Field Action responses and updates to regulatory agencies, ensuring timely submission to the appropriate regulatory authorities. + Responsible for compiling the… more
- Medtronic (Lafayette, CO)
- …+ Experience with global regulatory pathways such as 510(k) and EU MDR + Background or coursework in quality systems, including familiarity with ISO standards ... preparing and submitting regulatory filings for the US market and managing EU MDR compliance for the European market. You will collaborate closely with our regional… more
- West Pharmaceutical Services (Exton, PA)
- …regulatory affairs (RA) team's priorities. + Manage the preparation, review, and submission of complex global regulatory filings, information request responses, ... responsible for management of regulatory affairs projects associated with West's global portfolio of medical devices, combination products, SaMDs, and packaging… more
- ConvaTec (NJ)
- …/ EU MDR 2017/745: + 510(k) submissions + Preparation and submission of EU technical documentation + Experience of regulatory requirements for medical devices ... trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of… more
- Caldera Medical (Westlake Village, CA)
- …ensure timely approvals for market release. Review significant product submissions with manager and negotiate submission issues with agency personnel. * Reviews ... project teams you will ensure submissions are accurately prepared and comply with global regulations. The position is on-site at our Westlake Village location and… more
- Medtronic (Mounds View, MN)
- …trial and manages trials of a higher degree of complexity and may be global in nature. This role works independently and under only general direction. The position ... We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions. To learn more about Inclusion & Diversity… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- **Job Description Summary** Reporting to the Senior Manager , Regulatory Affairs, Microbiology, the Staff Regulatory Affairs Specialist is responsible for the ... Description** We are **the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health (TM) is… more
- Kelly Services (Irvine, CA)
- …in the application of Quality Management System Standard ISO 13485, MDD / MDR , and US FDA regulations + Demonstrable track record of successfully managing multiple ... is responsible for compiling the necessary documentation required for a regulatory submission including the generation of the technical content to maintain and… more