- Teva Pharmaceuticals (West Chester, PA)
- …to make a difference with. **The opportunity** The Senior Manager in Global Regulatory Medical Writing writes and edits clinical regulatory ... Senior Manager , Medical Writing -...documents include the proper content and context (from a regulatory medical writing perspective) and… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs, is responsible for preparing, filing and gaining ... timely regulatory clearance/approval for marketing. + Develops Regulatory team expertise in project management, writing ,...equivalent. + Minimum of 3 years' experience in a regulatory capacity within the medical device industry,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …the Global Senior Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not limited to analysis of requirements and resource ... + Strategic Leadership and Portfolio Alignment: + Facilitate development of global regulatory strategies for medical devices and digital health solutions,… more
- ICON Clinical Research (NC)
- Senior Manager , Regulatory Affairs - IVD ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an ... to join us on our mission to shape the future of clinical development. Sr Manager , Regulatory Affairs - IVD Location: US Remote, Portland, OR area preferred We… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure Division on-site ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge...medical fields. + Advanced degree + 8 years' Regulatory experience + Experience working in a broader enterprise/cross-division… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site at ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC** position will...strategies on complex issues + Work closely with in-country regulatory representatives, compile, prepare, and review medical … more
- J&J Family of Companies (Irvine, CA)
- …Learn more at https://www.jnj.com/medtech We are searching for the best talent for a ** Manager , Regulatory Affairs** . _The preferred location for this role is ... and relocation assistance is not provided. **Purpose** : The Manager , Regulatory Affairs, is a mid-level professional...Assessment Experience **required** . + Experience with Vision related medical device regulatory _highly desired_ . +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …the medical device classification, and connected technologies. + Provide regulatory guidance, compliance risk assessment, and strategic input to digital product ... and maintain standard operating procedures (SOPs), compliance frameworks, and internal regulatory guidance specific to non- medical device digital health… more
- Abbott (Alameda, CA)
- …**Qualifications** + 5+ years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …more than 110 countries and regions. **Summary:** Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish ... on labeling, labeling requirements, and implementation. Coordinate and submit all regulatory documentation for establishment of new / changed local market… more
- Danaher Corporation (Marlborough, MA)
- …about the Danaher Business System which makes everything possible. The Quality and Regulatory Support Manager for Cytiva is responsible for supporting the ... and Customers in a global environment by providing quality documents and regulatory support in ongoing projects, new product development, change control, and in… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …staff. **Minimum Requirements:** + Bachelor's degree + Minimum 5 years of strong Regulatory Affairs experience in the medical device and/or in vitro diagnostic ... of possible** BD is one of the largest global medical technology companies in the world. Advancing the world...This position will be working in BD-Connected Care on Regulatory Affairs projects that support the Pharmacy Automation business.… more
- Dentsply Sirona (Milford, DE)
- …functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing, new, and modified medical devices and ... implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other...Strong written and verbal communication skills. + Prior technical writing experience and proven track record with FDA and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …**Job Description** **POSITION OVERVIEW:** You will typically act as the Regional Regulatory Lead on the assigned products, compounds, indications or projects in ... Virology. With guidance, you will define the regulatory strategy, plans and objectives for the assigned products or projects. You will typically lead the … more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing , regulatory operations, etc.) to develop global ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- University of Utah (Salt Lake City, UT)
- …**Requisition Number** PRN43595B **Job Title** Compliance Officer **Working Title** Regulatory Compliance Manager - Hybrid/Remote **Career Progression Track** ... Incumbent is responsible for assisting the University in preparation for regulatory audits by developing, monitoring and updating quality controls and recommending… more
- Fujifilm (Albany, NY)
- **Position Overview** The Regulatory Compliance Manager (Corporate) is a member of the FUJIFILM Holdings America Corporation ("HLUS") Department reporting to the ... Corporate Compliance Director. The Compliance Manager will be responsible for managing the day-to-day operations...Collaborate closely with colleagues in Legal, IT, HR, Finance, Regulatory and other core functions in order to direct… more
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Project Manager position is responsible for implementing and coordinating key strategic projects according to scope and department ... activities, and communicating professionally and persuasively verbally and in writing . This position monitors milestones and identifies potential barriers to… more
- Pentax Medical (Montvale, NJ)
- … Medical provides endoscopic imaging devices and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN ... specialist will work under the guidance of a seasoned manager to ensure PENTAX Medical 's products for...Experience with biocompatibility requirements + Proven track record in writing major regulatory device submissions (ie 510(k)s),… more
- Takeda Pharmaceuticals (Boston, MA)
- …being used to support our mission. Duties will include the following, under the manager 's supervision + Support medical writing operations with day-to-day ... to the best of my knowledge. **Job Description** The Medical Writing Operations team is responsible for...QC checks of clinical documents intended for submission to regulatory agencies and ad hoc documents, as follows: +… more