- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in ... candidate will provide knowledge, understanding, interpretation, and utilization of regulatory guidance and regulations from various health authorities, as well… more
- Meta (Burlingame, CA)
- …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
- Abbott (Santa Clara, CA)
- …executives, and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… 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
- Stryker (Redmond, WA)
- …in Regulatory Affairs ) + Previous experience with Class II/III medical devices + Experience authoring regulatory submissions for product approval ... Washington.** **What you will do** 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
- Hologic (Louisville, CO)
- Regulatory Affairs Specialist, Medical Device Louisville, CO, United States Marlborough, MA, United States **Join Hologic's Surgical Division as a ... industry. **What You'll Bring:** **Experience** + 2-5 years in regulatory affairs , preferably within the medical device industry. + Proven experience… more
- Medtronic (Irvine, CA)
- …Medical Device Experience:** Minimum of 4 years of relevant experience in medical device regulatory affairs . + **510(k) Submission Experience:** ... or university required; advanced degree with a minimum of 2 years of experience in medical device regulatory affairs is a plus. + ** Regulatory … 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
- West Pharmaceutical Services (Exton, PA)
- …to human factors, combination products, delivery system and design controls. + Experience in medical device regulatory affairs and/or design control ... Director, Regulatory Affairs Requisition ID: 71273 Date:...Ability to comprehend principles of math, science, engineering, and medical device use. + Ability to handle… more
- Abbott (St. Paul, MN)
- …**Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification (RAC) is a ... and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist** to join Abbott's Vascular... regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices . +… more
- Kelly Services (Beachwood, OH)
- …by the Regulatory Affairs Professionals Society (RAPS). + Experience in medical device regulatory affairs + Demonstrated life-long learner; ... an exciting contract opportunity with one of our leading clients! **Title:** Regulatory Affairs Specialist **Location:** Cleveland, OH / Beachwood, OH… more
- Stryker (Salt Lake City, UT)
- …with a solid understanding of regulatory standards and practices. + Exposure to Medical Device Regulatory Affairs or Engineering through coursework, ... Fremont, CA or Salt Lake City, Utah as a Regulatory Affairs Specialist.** At Stryker, we're driven...experience working with US Class II and Class III medical devices . + Demonstrates strong analytical and… more
- J&J Family of Companies (Irvine, CA)
- …Devices sector within **Johnson & Johnson** , is recruiting for an intern for its ** Medical Devices Regulatory Affairs organization** . At **Johnson & ... develop the skills needed to succeed in a global organization. The Intern - ** Medical Devices Regulatory Affairs (MD RA)** opportunity will help you grow… more
- Medtronic (Lafayette, CO)
- …5 years of relevant experience **Nice to Have: Preferred Qualifications** + 7+ years of medical device regulatory affairs with roles showing increasing ... world. **A Day in the Life** As a **Principal Regulatory Affairs Specialist** at Medtronic, you will...standards. + Apply in-depth knowledge of FDA regulations, EU Medical Device Directive (93/42/EEC), Medical … 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
- Stryker (Columbia City, IN)
- …preferably with medical devices . + A minimum of 7 years of Medical Device Regulatory Affairs experience required. **Preferred** + Master's degree ... and global submissions. + Expertise in ISO standards and regulatory frameworks for medical devices . + Articulates the organization's strategic vision… 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
- GRAIL (MD)
- …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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …or medical -related field. + Minimum of 2-3 years of Medical Device and/or Pharmaceutical Regulatory Affairs experience. **Click on Apply if this ... self. Become a **maker** **of possible** with us. The Regulatory Affairs (RA) Specialist will be responsible... regulatory files (eg master files, GSPR packages, medical device dossiers) and respond to health… more
