- Oracle (Tallahassee, FL)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Oracle (Tallahassee, FL)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing… 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
- Actalent (Miami, FL)
- …skills. Additional Skills & Qualifications + Knowledge of FDA regulations. + Experience in medical device regulatory affairs . + Bilingual proficiency. + ... Job Title: Regulatory Affairs Specialist Job Description We...+ Oversee Adverse Event (US) and Vigilance Reporting (OUS) regulatory requirements. + Responsible for device registration… more
- GRAIL (Tallahassee, FL)
- …, development, clinical affairs , quality, or program management within the IVD, medical device , or pharmaceutical industries is required. + Regulatory ... 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 is required.… more
- Dentsply Sirona (Sarasota, FL)
- …Years and Type of Experience: + 5(+) years of experience in regulatory affairs , preferably in the medical device industry. + Experience with leading ... + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited...13485, EU MDR). + Experience with software as a medical device , AI and/or medical … more
- Dentsply Sirona (Sarasota, FL)
- …affairs , or a related discipline + 1-5 years of experience in regulatory affairs , preferably in the medical device industry + Experience with ... international regulatory submissions to obtain and maintain regulatory approvals for medical devices, including 510(k)...work effectively in a team environment + Knowledge of regulatory affairs principles and practices + Ability… more
- Actalent (Miami, FL)
- …Regulatory affairs , Regulatory , document control, bilingual, fda, medical device , RAPS Additional Skills & Qualifications -Bachelors degree in ... Responsible for Adverse Event (US) and Vigilance Reporting (OUS) regulatory requirements * Responsible for Device Registration...Engineering / Regulatory Affairs -1-3 years experience -Strong Technical… more
- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- Fujifilm (Tallahassee, FL)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more