- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... Experience** + 3-5 years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience + Experience with US FDA regulations (Title… 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 ... device is a plus). Demonstrates profound knowledge and expertise in Active Medical Device international regulations, focus on US/Canada/MDR and APAC is a… more
- Bausch Health (Bothell, WA)
- … required + Must have a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on US Canada ... written and communication skills. + Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR… more
- Insight Global (Sarasota, FL)
- …Experience with quality checks and audits in a manufacturing environment. Knowledge of regulatory requirements for medical device manufacturing. We are a ... Job Description We are seeking an experienced Medical Device Operations Supervisor to oversee 75% of our operations lifecycle, including staging, filling,… more
- Fujifilm (Nashville, TN)
- …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...other applicable laws. + Keep abreast of legislative and regulatory changes with respect to healthcare and other relevant… more
- Sanofi Group (Morristown, NJ)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... with 10 years regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory experience required. + At least 10… 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. 3+ years ... The Regulatory Affairs position within Regulatory Policy & Intelligence (RP&I) is responsible for contributing to or leading impact assessments and for changes… 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. ... Job Title: Director of Regulatory and Medical Affairs Location: Malvern,...Manage and maintain ongoing submissions such as annual reports, medical device facility registrations and device… more
- Medtronic (Santa Rosa, CA)
- …+ Minimum of 7 years of direct Regulatory Affairs experience within the medical device or other regulated industry, + Or advanced degree with a minimum ... of 5 years of Regulatory Affairs experience. + Medical device industry experience with Class I/II/III/IV software products. **Nice To Have:** + Direct … more
- 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