- Hologic (Marlborough, MA)
- Manager , Regulatory Affairs ( IVD On-Market/Sustaining) San Diego, CA, United States Marlborough, MA, United States We are hiring in our Diagnostics ... Diego or Marlborough campus, and are looking for a Regulatory Affairs Manager , responsible for...with a minimum of 8-10 years direct experience in Regulatory Affairs within the IVD … more
- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. **Sr. Manager IVD Strategy & Operations - Precision Medicine Unit** **What you will ... leading forums, meetings, and working groups to align on IVD regulatory objectives + Forum Management: Plan,...experience **Preferred Qualifications:** + Bachelor's degree in life sciences, regulatory affairs , or a related field (advanced… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As an Senior Manager , Global Regulatory Affairs , Precision Medicine, you will help ... schedule in either Parsippany, NJ or Foster City, CA. **Responsibilites:** + Represent Regulatory Affairs Precision Medicine or Dx Regulatory in… more
- Amgen (Washington, DC)
- …alongside other innovative, driven professionals in this meaningful role. **Companion Diagnostic Regulatory Affairs Manager ** **Live** **What you will do** ... or Regulatory experience **Preferred Qualifications:** + MS Degree + Degree in Regulatory Affairs , Life Sciences, or Engineering + 6 plus years of experience… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …best self. Become a **maker of possible** with us. **Job Overview** The Staff Regulatory Affairs Specialist is part of the team responsible for Core Business ... + Requires a minimum of 5 years' experience in regulatory affairs in the device/diagnostic industry. +...Ability to interpret new regulations and understand and interpret IVD regulatory requirements. + RAC Certification is… more
- ThermoFisher Scientific (Austin, TX)
- …in Biology, Chemistry, bioengineering, or related science + At least 5 years of IVD Regulatory Affairs experience + Hands-on experience with 510(k), PMA, ... Description** **Responsibilities:** Join Thermo Fisher Scientific Inc. as a Manager , Regulatory Affairs , and play...assays + Support EU representatives in their creation of CE/ IVD Technical Files + Support global regulatory … more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC**... representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …Minimum Requirements: + Bachelor's degree. Science background is preferred. 3+ years in regulatory affairs , medical device/ IVD industry required + or MS ... and labeling requirements, with some oversight from more senior regulatory specialist / manager . + May begin...degree with 1 year in regulatory affairs , medical device/ IVD industry… more
- Abbott (San Diego, CA)
- …world's greatest healthcare challenges. This Director will be a highly experienced manager , whose decisions tend to be more tactical and operational, is accountable ... trials comply with Good Clinical Practice (GCP) guidelines and relevant regulatory standards. + Manage clinical trial budgets, timelines, and resources effectively… more
- Hologic (San Diego, CA)
- …leadership of clinical program strategy together with key stakeholder departments (eg R&D, Regulatory Affairs , Marketing, Scientific Affairs ). + Leads and ... Clinical Program Manager San Diego, CA, United States Discover a...and objectives + Excellent working knowledge of GCP, clinical affairs , and regulatory affairs The… more