- Meta (Burlingame, CA)
- …the combination of AI with great form factors can do. We are seeking an experienced medical devices regulatory affairs professional to help us execute ... products with distribution into many worldwide markets. **Required Skills:** Medical Devices Regulatory Affairs...Medical Device Directive & European Union Medical Device Regulation, FDA regulatory … more
- System One (Malvern, PA)
- …in life sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with management responsibilities. + Strong ... Job Title: Director of Regulatory and Medical Affairs ...and global regulatory requirements for class II medical devices including but not limited to… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746 Date: Jul 10, 2025 Location: Exton, Pennsylvania, US Department: ... regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and… more
- Medtronic (Irvine, CA)
- …relevant experience + Or advanced degree with a minimum of 2 years of experience in medical device regulatory affairs **This is not a remote position** ... **Nice To Have** + 4 years of experience in medical device regulatory affairs + Excellent technical knowledge of medical products and understanding… more
- Abbott (Plymouth, MN)
- …**Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification (RAC) is a ... their lives. **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist** to join Abbott's Electrophysiology... regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices . +… more
- GE HealthCare (Madison, WI)
- …by the Regulatory Affairs Professionals Society (RAPS). + Experience in medical device regulatory affairs + Demonstrated life-long learner; ... pulse oximetry. You will work within a team of Regulatory Affairs professionals to ensure GE HealthCare...labeling compliance, etc. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is… more
- Cardinal Health (Boston, MA)
- …**_Qualifications_** + Bachelors in related field, preferred + 2+ years' experience in Medical Device Regulatory Affairs /Quality experience preferred + ... **_What Regulatory Affairs contributes to Cardinal Health_**...Brand, Presource, and Sustainable Technologies businesses and range of medical devices . + Maintain regulatory … more
- Stryker (Weston, FL)
- …3+ years of experience in an FDA regulated industry + 2+ years of experience in medical device regulatory affairs + Thorough understanding of FDA, ... Europe, and international medical device regulations + Experience drafting regulatory submissions... Affairs ) + Previous experience with Class II/III medical devices + Previous experience drafting 510(k)s… more
- Astrix Technology (Fort Worth, TX)
- …EC Certificates (MDD /MDR) and associated documentation. **Key Requirements:** + 4+ years in medical device regulatory affairs + Experience with European ... ** Regulatory Affairs Specialist** Clinical Fort Worth,...compliance and lifecycle change management for medical devices . + Works closely with site regulatory … more
- Sanofi Group (Cambridge, MA)
- …responsibilities. **About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...+ Dealt effectively with cross-functional groups, which may include Medical , Legal, Marketing, etc. + Experience managing others is… more
- J&J Family of Companies (Santa Clara, CA)
- …help efficiently and effectively meet assigned regulatory requirements for Shockwave Medical . The Senior Regulatory Affairs Specialist combines knowledge ... 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
- Abbott (St. Paul, MN)
- …business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society Certification ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- J&J Family of Companies (Santa Clara, CA)
- …+ Other duties as assigned. **Requirements** + Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree; ... aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease...for Shockwave Medical , Inc. (SWMI). The Sr. Regulatory Affairs Specialist combines knowledge of scientific,… more
- Belcan (Whippany, NJ)
- …accurate content for external and internal use. * Collaborate with cross-functional teams including Medical Affairs , Regulatory , and Legal to review and help ... Senior Manager, Medical Affairs Communications - Oncology Job...* 1-2 years of experience in the pharmaceutical or medical device industry * Prior experience in… more
- Bausch Health (Bothell, WA)
- …Bachelors Degree Required Life science or technical discipline preferred. Minimum 6 years regulatory experiences in MNC medical device company (aesthetic ... values drive our collective progress and impact. The Manager, Regulatory Affairs will be responsible for: +...a plus). Demonstrates profound knowledge and expertise in Active Medical Device international regulations, focus on US/Canada/MDR… more
- Bausch Health (Bothell, WA)
- …your skills and values drive our collective progress and impact. The Manager Regulatory Affairs provides direct support to Solta operations for their globally ... + Act as the key liaison between the global regulatory affairs team and other departments, such...a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact… 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
- 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
- J&J Family of Companies (Santa Clara, CA)
- …* Other duties as assigned. **Requirements** * Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree; ... Johnson is hiring for a **Sr.** ** Regulatory Affairs Specialist (Remote) - Shockwave Medical ** to...aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease… 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