- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …and Experience: Bachelor's Degree. Science background is preferred. 3+ years in regulatory affairs required, medical device /IVD industry preferred. ... A member of the RA team responsible for developing regulatory strategy and assessing regulatory risks for...worldwide approval. They may also perform and/or assist with medical device reporting or field actions. This… more
- Stryker (Redmond, WA)
- …Degree (Masters in Regulatory Affairs) + Previous experience with Class II/III medical devices + Experience authoring regulatory submissions for product ... Washington.** **What you will do** As part of the Medical Regulatory Affairs team, you will work...team, you will work with the team to maintain medical devices on the market and ensure… more
- Globus Medical, Inc. (Audubon, PA)
- …or equivalent; Engineering degree is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining...orthopedic medical devices ; + Experience in medical … more
- Abbott (Plano, TX)
- … device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines.... regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry. + 3-5+… more
- Abbott (Santa Clara, CA)
- …providing strategic and predictable Regulatory Services in collaboration with the medical device business units that Leveraged Services team supports. **The ... on regulatory activities and works with the medical device business units that Leverage Services...experience in regulatory affairs; highly preferred with medical devices . + At least 5 years… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …technical discipline required (eg, engineering, bioengineering, biology, chemistry). + Minimum 5 years Regulatory Affairs experience in medical device or in ... has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing...regulatory authority personnel (eg FDA, Notified Bodies) in medical device and in vitro diagnostic areas.… more
- Abbott (Plymouth, MN)
- …of international regulatory affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly ... scientific affairs function. **Preferred** **Qualifications** + 4+ years of related regulatory submission experience from medical device , pharmaceutical,… more
- Terumo Aortic (Sunrise, FL)
- …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...in medical device regulatory affairs if no degree. +...and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …other global regulatory agencies. **Responsibilities include:** + Write drug and medical device regulatory submissions including NDA, ANDA, Prior ... on regulatory activities for existing drug and medical device products to create savings for...United States, European, and international regulations and standards covering medical devices . + Demonstrated organizational, planning, and… more
- Medtronic (Santa Rosa, CA)
- …your applicant profile_ + Bachelor's degree in a technical discipline + Minimum 4 years of medical device regulatory experience + Or minimum 2 years of ... medical device regulatory experience with an advanced degree...medical device regulatory experience with an advanced degree N **ice To...of regulatory submissions for Class IIb /III/IV medical devices in the US, Japan, or… more