- Sanofi (Cambridge, MA)
- …Life Sciences or other relevant discipline 8+ years of experience within pharmaceutical or medical device Regulatory Affairs , with 5+ years specifically ... Job Title: Director, US Regulatory Affairs - Advertising and Promotion...without relying on authority, including participating in cross-functional groups ( medical , legal, regulatory , etc.) to lead toward… more
- Sanofi (Morristown, NJ)
- …medical leads, data managers, statisticians, clinical supplies managers and regulatory affairs specialists, etc.. ensure compliance with relevant regulations, ... Practice (GCP) and internal SOPs contribute to the development of new drugs and medical devices through clinical trials May be a core team member of the Global… more
- Oracle (Oklahoma City, OK)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Meta (New York, NY)
- …a scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. ... regulatory affairs specialist to join our medical devices compliance team. You will get...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- Stryker (Redmond, WA)
- … Regulatory Affairs ). + Previous experience with US Class II/III medical devices . + Experience authoring regulatory submissions for product approval. ... based **Hybrid** in **Redmond, Washington.** As part of the Medical Regulatory Affairs team, you...team, you will work with the team to maintain medical devices on the market and ensure… more
- Terumo Aortic (Sunrise, FL)
- …(or related field) from an accredited college or university and 3 years direct experience in medical device regulatory affairs + Minimum 5 years direct ... experience in medical device regulatory affairs if no...and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record… more
- Abbott (Pleasanton, CA)
- …Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification (RAC) is a ... treatment. **The Opportunity** We are recruiting for a **Senior Regulatory Affairs Specialist** to join our team...regulations and submissions. + Must be familiar with relevant regulatory requirements for medical devices … more
- Teleflex (Morrisville, NC)
- …in a science or engineering field, or equivalent work experience. * 5+ years of Medical Device Regulatory Affairs experience, domestic and international. ... Senior Regulatory Affairs Specialist **Date:** Dec 2,...- The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose… more
- Sanofi Group (Morristown, NJ)
- …Sciences or other relevant discipline + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs , with 5+ years specifically ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...without relying on authority, including participating in cross-functional groups ( medical , legal, regulatory , etc.) to lead toward… more
- GRAIL (Olympia, WA)
- …management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals. + Effective… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs , Medical is responsible...5 years of relevant experience + 2+ years of medical device regulatory experience preferred… more
- J&J Family of Companies (Santa Clara, CA)
- …States of America **Job Description:** Johnson & Johnson is hiring for a **Principal Regulatory Affairs Specialist- Shockwave Medical ** to join our team. The ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease… more
- Globus Medical, Inc. (Audubon, PA)
- …experience in medical device industry or equivalent, preferably within orthopedic medical devices ; Regulatory Affairs experience is a plus. + ... At Globus Medical , we move with a sense of urgency...lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting… more
- Avania (Boston, MA)
- …are Hiring - Regulatory & Market Access Interns x2 We are seeking two, part-time Medical Device Regulatory Affairs & Quality Interns to join the ... efforts. + Content Development + Contribute to creation of medical device regulatory and quality-focused...Regulatory Affairs students with interest in medical devices . + Strong research, writing, and… more
- Actalent (Lake Forest, CA)
- …Regulatory reporting, Test plan, Regulatory compliance, Compliance, Quality engineering, Medical device , Regulatory affairs , CMC, manufacturing ... Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global...development and sustaining activities. - Strong understanding of global medical device regulations (eg, FDA CFR, EU… more
- Pentax Medical (Montvale, NJ)
- … and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are an established medical ... future of medical technology. Responsibilities of Senior Regulatory Affairs Specialist : + Coordinate with...regulated employer + Thorough understanding of domestic and international regulatory requirements for medical devices … more
- Kelly Services (Norcross, GA)
- …area for a Principal, Regulatory Affairs (Transfusion).** Principal, Regulatory Affairs - IVD / Medical Devices Location: Norcross, GA Industry: ... Regulatory Affairs professional to manage pre-market regulatory activities for medical devices ,...* Knowledge of FDA 21 CFR 820, Health Canada Medical Device Regulations, MDSAP, and exposure to… more
- Abbott (Plymouth, MN)
- …etc.), math, engineering, or medical fields. + Master's degree in Regulatory Affairs . + Regulatory experience with capital equipment including ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Alameda, CA)
- …+ 5+ years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Alameda, CA)
- …. 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. ... regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . ....device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices … more
