- Abbott (Santa Clara, CA)
- …executives, and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… 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 degree. + Knowledge of US and European regulatory processes, including Class III is strongly… 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,...Supporting EU MDR compliance and lifecycle change management for medical devices. + Works closely with site regulatory… more
- Stryker (Fremont, CA)
- …of regulatory standards and practices. + Minimum of 1 year of experience in Medical Device Regulatory Affairs or Engineering. **Preferred** + RAC ... Stryker's Neurovascular Division in Fremont, CA as a Senior Regulatory Affairs Specialist.** At Stryker, we're driven...experience working with US Class II and Class III medical devices. + Demonstrates strong analytical and writing skills,… more
- GRAIL (Menlo Park, CA)
- …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
- 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
- Hologic (Louisville, CO)
- Regulatory Affairs Specialist, Medical Device Louisville, CO, United States Marlborough, MA, United States **Join Hologic's Surgical Division as a ... You'll Bring:** **Experience** + 2-5 years in regulatory affairs , preferably within the medical device industry. + Proven experience preparing … 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
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …Bachelor's Degree required. Science background is preferred. Specialist: 3+ years in regulatory affairs , medical device /IVD industry required. ... The Regulatory Affairs position within Regulatory Policy & Intelligence (RP&I) is responsible for contributing to or leading impact assessments and for… more
- Medtronic (Mounds View, MN)
- …degree in a technical discipline + Minimum of 7 years of direct Regulatory Affairs experience within the medical device or other regulated industry, + Or ... degree with a minimum of 5 years of Regulatory Affairs experience. + Medical device industry experience with Class I/II/III/IV software products. **Nice… more
- Actalent (Grand Rapids, MI)
- …related field. + 5+ years of experience in a regulated pharmaceutical/ medical device industry. + Hands-on experience in Regulatory Affairs with growing ... Job Title: Quality Assurance Associate Job Description The Regulatory Affairs Specialist plays a crucial...for this temporary role may include the following: * Medical , dental & vision * Critical Illness, Accident, and… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …**Experience:** + A minimum of 5 years of proven experience in regulatory affairs , ideally within the medical device or pharmaceutical industry. + Strong ... required. NO relocation assistance. **Key Responsibilities** + As a Regulatory Affairs Specialist II, you will be...as well as state and international regulations related to medical devices. + Demonstrate ability to maintain regulatory… more
- J&J Family of Companies (Santa Clara, CA)
- …to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Regulatory Affairs Manager 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
- Bayer (Indianola, PA)
- …Excel, Powerpoint); + Some laboratory experience is highly desirable; + Coursework in medical device development/ regulatory affairs is highly desirable. ... Employees can expect to be paid a salary of approximately between $23.20 to $44.20. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This salary… more
- J&J Family of Companies (Danvers, MA)
- …field of heart recovery. **You will be responsible for** : + Have Regulatory Affairs experience in the medical device industry with a track record of ... commercial medical devices. + Be passionate about Regulatory Affairs impact in support of the...Affairs experience (5+ w/ Advanced Degree) in the Medical Device industry with a track record… more
- University of Utah (Salt Lake City, UT)
- …a 9-month (annually Aug. 16 - May 15) Career-line faculty position in the area of Regulatory Affairs , Medical Device Design and Regulatory Science. ... and strong interest in teaching Regulatory Affairs , Regulatory Science, and medical device design courses. Practical experience in regulatory … more
- Caldera Medical (Westlake Village, CA)
- …Sciences, Biomedical Engineering, or a related field. * 5-7 years of regulatory affairs experience in the medical device industry. * Strong understanding ... Sr. Regulatory Affairs Specialist 100% ONSITE in... Regulatory specialist, you will develop and implement medical device regulatory strategies to… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …required (eg, engineering, bioengineering, biology, chemistry). + Minimum 5 years Regulatory Affairs experience in medical device or in vitro diagnostic ... your expertise and grow in your career. Our Staff Regulatory Affairs Specialist position is primarily focused...regulatory authority personnel (eg FDA, Notified Bodies) in medical device and in vitro diagnostic areas.… more