- Cepheid (Miami, FL)
- …Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) ... (CQA) Certification ISO 9001:2015 process and assessment certification activities Regulatory Intelligence program Technical Writing Cepheid, a Danaher operating… more
- Cytiva (Miami, FL)
- …control testing, and sterility assurance processes in a highly regulated medical device environment.This role involves conducting laboratory analyses, ... 14644, sterility processes, and cGMP (current Good Manufacturing Practices) in medical device product manufacturing.Experience with Water, Endotoxin, Bioburden,… more
- Beckman Coulter Diagnostics (Miami, FL)
- …plus if you also possess:Experience working in FDA-regulated industries or medical device manufacturing environments.Professional certifications such as CQE, ... to internal quality standards, customer requirements, and applicable external regulatory frameworks. Provide structured feedback and corrective action follow-up to… more
- System One (Malvern, PA)
- …or equivalent, in life sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with management responsibilities. ... Manage and maintain ongoing submissions such as annual reports, medical device facility registrations and device...and global regulatory requirements for class II medical devices including but not limited to… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices ...years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience +… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... Description:** Johnson & Johnson is hiring for a **Sr. Manager, Regulatory Compliance - Shockwave Medical ** to join our team located in **Santa Clara, CA.** At… more
- 3M (Maplewood, MN)
- …Public Health, Environment, Safety or other EHS program + Experience working in regulatory , medical device , product responsibility or EHSR corporate staff ... Job Description: Senior Regulatory Affairs Associate Collaborate with Innovative 3Mers Around...may be eligible for a range of benefits (eg, Medical , Dental & Vision, Health Savings Accounts, Health Care… 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 ... degree with 1 year in regulatory affairs, medical device /IVD industry required + 1+ year experience with FDA Knowledge, special skills and/or abilities: +… more
- Caldera Medical (Westlake Village, CA)
- …your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR,… more
- Abbott (Santa Clara, CA)
- …knowledge of US FDA Medical Device Regulatory Requirements for class III medical devices and EU Medical Device Regulations for new and on ... device . This individual will lead and coordinate global Regulatory Affairs activities including regulatory strategies, submissions...they relate to Class III implantable medical devices is required. Working knowledge of regulatory … more
- Abbott (Plymouth, MN)
- …+ Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices . + Experience of working within ... + Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements...years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification… more
- Abbott (Alameda, CA)
- … medical device regulations and submissions. + Familiar with relevant regulatory requirements for medical devices , drugs and/or biologics including ... life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceuticals, medical devices , and/or… more
- J&J Family of Companies (Irvine, CA)
- …in the medical device industry with at least 6+ years in Regulatory Affairs of Medical Devices . + Minimum 2 years of supervisory experience. ... devices containing software _strongly preferred_ . + Experience in international regulatory requirements (APAC/LATAM/EMEAC) for medical devices _highly… more
- Abbott (Alameda, CA)
- … fields. + 1+ year of Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review of labeling, promotional, and or ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Sanofi Group (Cambridge, MA)
- …GRA Device representative in project/product teams + Develop innovative and sustainable medical device regulatory strategies + Provide regulatory ... regulatory activities associated with Sanofi's combination product and medical device portfolio in the Specialty Care...be key deliverables. **Knowledge:** + Proven experience in global medical devices regulatory for drug-led… more
- J&J Family of Companies (Irvine, CA)
- …in the medical device industry with at least four (4) years in Regulatory Affairs of Medical Devices . + Class III PMA experience is **required** . ... 510K, and/or PMA submissions and EU Technical Document for medical devices for commercialization in the USA...._preferred_ . + Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations,… more
- Stryker (Redmond, WA)
- …(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...regulatory agencies. + Previous experience with Class II/III medical devices . Health benefits include: Medical… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Job Responsibilities** The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion ... years of experience in Regulatory Affairs working with complex medical device systems and software strongly preferred. * Experience working with external… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... filings (TGA, Health Canada, Shonin, CFDA, etc.). Experience with pre- and post-market medical device submissions support such as 510(k), IDE, PMA, EU Technic… more
- LSI Solutions (Victor, NY)
- …to gather regulatory intelligence regarding updates to US and international medical device regulations, and supporting Rest-of-World (ROW) regulatory ... govern the design, development, manufacturing, and distribution of our medical devices . REPORTS TO: REGULATORY ... medical records. + A rudimentary understanding of Regulatory principles that govern medical device… more
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