- Beckman Coulter Diagnostics (Miami, FL)
- …we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always ... to internal quality standards, customer requirements, and applicable external regulatory frameworks. Provide structured feedback and corrective action follow-up to… more
- Sanofi Group (Framingham, MA)
- …and roll-out of the Sanofi Quality Management System in line with US FDA cGMP regulatory requirements, Pharmaceutical Quality System ICH Q10 and Sanofi ... **Job Title:** Compliance Head- US FDA **Location** : Framingham, MA, Morristown, NJ **Job...Morristown, NJ **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the… more
- Rush University Medical Center (Chicago, IL)
- …engineering program, including vendor oversight. Strong knowledge of Joint Commission, CMS, FDA , and other healthcare regulatory standards. Experience with ... management of biomedical equipment. Ensure compliance with The Joint Commission, CMS, FDA , and other regulatory requirements. Lead and manage relationships with… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents. + Provide regulatory input during the ... Guidance and SaMD related Guidance. + Knowledge of international regulatory requirements (eg, FDA QSR, ISO 13485,...and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum… more
- BeOne Medicines (San Mateo, CA)
- …**Essential Functions of the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically ... and advice on FDA interactions. + Oversees the preparation of NA regulatory documentation and ensures timelines are met, including the review of NA submission… more
- IQVIA (Wayne, PA)
- …true expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... and consortia + Lead development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED + Contribute to the… more
- Houston Methodist (Houston, TX)
- …study team and sponsor's regulatory team. This position communicates with regulatory affairs office for FDA submissions across multiple studies of different ... **SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH… more
- Medtronic (Minneapolis, MN)
- …develop solutions to complex US promotional issues. + Interact directly with FDA and/or indirectly with international regulatory agencies on most ... life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with...feedback and on-going support to product development teams for regulatory issues and questions. + Prepare FDA ,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- … affairs, with a focus on medical device systems + Knowledge of international regulatory requirements (eg, FDA QSR, ISO 13485, IEC 62304) + Solid understanding ... Experience working with regulatory submissions, interactions with regulatory agencies (eg, FDA , BSI or other...and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum… more
- Globus Medical, Inc. (Audubon, PA)
- …team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering ... as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- J&J Family of Companies (Horsham, PA)
- …subject to applicable laws, regulations, guidelines and company policies (including FDA regulatory promotional practice laws, regulations, policies, guidelines ... pharmaceutical or biopharmaceutical industry is required. + Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and… more
- Fortive Corporation (Irvine, CA)
- …to regulatory affairs management in order to facilitate compliance with all FDA and other US and international regulatory requirements throughout the product ... regulatory agency regulations and interpretations. + Writes, coordinates, compiles, and submits Regulatory documents to FDA and other Regulatory Agencies,… more
- Abbott (Santa Clara, CA)
- …of global regulatory submission experience, with substantial knowledge of US FDA Medical Device Regulatory Requirements for class III medical devices and ... Abbott is a global healthcare leader that helps people live more fully...CA currently has an on-site opportunity for a **Senior Regulatory Affairs Manager - Transcatheter** **Mitral Valve Replacement** within… more
- Abbott (St. Paul, MN)
- …trial operations and product market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory ... Abbott is a global healthcare leader that helps people live more fully...communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA… more
- UTMB Health (Galveston, TX)
- …that utilize the US FDA GLP regulations as a reference standard. The Regulatory Scientist I / II may also function as a Principal Investigator for extramurally ... reviews with that department. **SALARY:** Commensurate with experience **_Official Regulatory Statement for Healthcare jobs' Job Descriptions_** :… more
- Abbott (St. Paul, MN)
- …communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other ... Abbott is a global healthcare leader that helps people live more fully...requests for product release. * May interface directly with FDA and other regulatory agencies if so… more
- Abbott (Plymouth, MN)
- … affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory ... regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies,… more
- Abbott (Plymouth, MN)
- …communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other ... Abbott is a global healthcare leader that helps people live more fully...to support Abbott customers. + May interface directly with FDA and other regulatory agencies if so… more
- Abbott (Sylmar, CA)
- …guidance on regulatory requirements and risk mitigation. + Interface with regulatory agencies (eg, FDA , Notified Bodies) and manage responses to inquiries ... Abbott is a global healthcare leader that helps people live more fully...currently has an onsite opportunity for a Manager of Regulatory Affairs in the Cardiac Rhythm Management Business. This… more
- Abbott (Alameda, CA)
- …on future actions. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies, ... Abbott is a global healthcare leader that helps people live more fully...levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will work… more
