- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …US, EU, and other global regulatory requirements are met. + Evaluates medical device regulations and leads development of global regulatory strategies ... Specialist independently supports projects to bring new and modified medical devices to market and ensure ongoing...4 years Regulatory Affairs experience in the medical device industry preferred **Preferred Qualifications:** +… more
- Medtronic (Irvine, CA)
- … Device Experience:** Minimum of 4 years of relevant experience in medical device regulatory affairs. + **510(k) Submission Experience:** Proven history ... university required; advanced degree with a minimum of 2 years of experience in medical device regulatory affairs is a plus. + ** Regulatory Knowledge:**… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …engineering, bioengineering, biology, chemistry); _advanced degree preferred_ + Minimum 3 years of Regulatory Affairs experience in medical device or in ... global regulatory agencies + Experience in negotiating with regulatory authority personnel in medical device and in vitro diagnostic areas +… more
- Oura (San Francisco, CA)
- … affairs, or a related field; advanced degree preferred. + 8+ years of regulatory affairs experience in medical devices , digital health, or wearable ... of the office. We are looking for a Director, Regulatory Affairs and Quality Assurance to play a key...external audits. + Deep understanding of software as a medical device (SaMD) and cybersecurity regulations. +… more
- Roche (Indianapolis, IN)
- … device advertising and industry best practices with deep understanding of regulatory frameworks that affect medical device advertising and marketing. + ... on advertising, marketing, and/or promotion for prescription drugs, biologics, or medical devices . + Strong understanding of the regulatory landscape and… more
- West Pharmaceutical Services (Exton, PA)
- …5 years Bachelor's with 5+ years required; or + Master's degree/PhD 2+ years medical device regulatory experience required **Preferred Knowledge, Skills and ... Sr. Specialist, Regulatory Affairs, Product Stewardship Requisition ID: 69466 Date:...legislations (eg California Prop 65, RoHS, Conflict Minerals, EU Medical Device Regulation) for all West global… more
- J&J Family of Companies (Palm Beach Gardens, FL)
- …relevant regulatory experience (6+ years with Master's, 5+ years with PhD); Medical Device regulatory experience _strongly preferred_ . + Experience with ... US and European medical device regulatory processes **required** . + Experience in preparing and submitting US regulatory files (510(k)s, PMAs) as well… more
- GE HealthCare (Madison, WI)
- …by the Regulatory Affairs Professionals Society (RAPS). + Experience in medical device regulatory affairs + Demonstrated life-long learner; eagerness ... **Job Description Summary** A trusted regulatory subject matter expert to provide guidance to...labeling compliance, etc. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Experience + Minimum of 5 years of directly related Regulatory and Regulatory Operations experience in medical devices and/or in vitro diagnostic ... of possible** BD is one of the largest global medical technology companies in the world. Advancing the world...responsible for support of a variety of international related regulatory activities continuous improvement and regulatory projects.… 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 MDR ... leader dedicated to helping people see brilliantly. The largest device company in the world - with complementary businesses...compliance and lifecycle change management for medical devices . + Works closely with site regulatory … more