- Abbott (St. Paul, MN)
- …for the treatment of structural heart disease. **The Opportunity** We are recruiting for a ** Regulatory Affairs Project Manager** to join our team on-site in ... our St. Paul, MN location. This individual contributor leads project submissions for FDA and EU regulatory ...components. **What You'll Work On** + Develops sound global regulatory strategies for new and modified medical … more
- AbbVie (Irvine, CA)
- …to a PhD degree in a scientific field, plus 2 years' experience in regulatory affairs . + Experience in US medical devices regulatory affairs is ... Follow Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US regulatory affairs… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting… more
- J&J Family of Companies (West Chester, PA)
- Regulatory Affairs Specialist II (DePuy Synthes) - Medical Device Business Services, Inc. - 2406175724W **Description** DePuy Synthes, Inc. is currently ... Regulatory Affairs processes. * Represents Regulatory Affairs on cross-functional project ...Chester **Organization** Medical Device Business Services, Inc (6029) **Job Function** Regulatory Affairs **Req ID:**… more
- J&J Family of Companies (Raynham, MA)
- Regulatory Affairs Specialist I (Depuy Synthes/Spine) - Medical Device Business Services, Inc. (1 of 2) - 2406183699W **Description** DePuy Synthes, part of ... processes practices for Regulatory Affairs processes. * Represents Regulatory Affairs on cross-functional project teams, guiding and supporting… more
- Medtronic (Santa Rosa, CA)
- …in your applicant profile. + Bachelor's degree. + Minimum of 7 years of direct Regulatory Affairs experience within the medical device industry + Or advanced ... with functional team members to ensure clear communication of project /program objectives, deliverables, and timing of key milestones. +...degree with a minimum of 5 years of Regulatory Affairs experience within the medical… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …various business areas (Marketing, Market Access, Sales Training, Communications/Public Relations, Legal, Medical Affairs , and Regulatory Affairs ). + ... and review submission packages, labeling revisions, and promotional materials for regulatory compliance. In addition,collaborateswith Medical Affairs … more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. **Head of CMC Regulatory Affairs - Small Molecules** **KEY RESPONSIBILITIES** The Head of ... CMC Regulatory Affairs - Small Molecules is responsible...is deeply integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams and overall goals. The role will report… more
- STERIS (Alpharetta, GA)
- Senior Manager, Regulatory Affairs Biocides - Remote Req ID: 41369 Job Category: Regulatory Affairs Alpharetta, GA, US, 30004 Description: At STERIS, we ... around the globe. Position Summary The mission of the Regulatory Affairs group is to implement effective... compliance as assigned by upper management. + Provide regulatory guidance and support to project teams… more
- Amazon (Bellevue, WA)
- …as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products. ... used to drive multi-million dollar businesses and reporting to senior leadership - . Regulatory Affairs Certification (RAPS) - . Drug and Biologics regulatory… more
- Edwards Lifesciences (Irvine, CA)
- …direction and guidance to smaller project teams to execute tactical regulatory affairs projects and/or initiatives including preparation and oversight of ... you will make an impact:** As a Senior Specialist, Regulatory Affairs , you work with other functional...variables with accountability for successful completion within scope of project deliverables + Representing the regulatory function… more
- Boehringer Ingelheim (Ridgefield, CT)
- …reflect Boehringer Ingelheim's high regard for our employees. The Executive Director, Regulatory Affairs Excellence is responsible to establish and promote a ... culture of excellence across all areas of the regulatory affairs department. This leadership role focuses...the way of operating. + Leads the team of Regulatory Project Managers to develop and implement… more
- University of Colorado (Aurora, CO)
- …Anschutz Medical Campus** **Department: Gates Institute** **Job Title: Regulatory Affairs Program Director** **Position #00819327 - Requisition #32624** ... Regulatory Affairs Program Director - 32624...project teams, and continuously evaluating the feasibility of regulatory strategic plans. + Leading cross-functional collaboration to ensure… more
- ICU Medical (Lake Forest, IL)
- Job Title Manager, Regulatory Affairs - Electromechanical Devices FLSA Status Exempt Work Arrangement Hybrid Position Summary The Manager, Regulatory ... * RAC Certification preferred. * Eight plus years of medical device industry experience with a minimum of five...industry experience with a minimum of five years in regulatory affairs with direct experience and authoring… more
- J&J Family of Companies (Columbus, OH)
- …years with a Bachelor's degree or Minimum of 3 years with an advanced degree * Regulatory affairs experience in the medical device industry with a track ... Senior Regulatory Affairs Specialist - 2406173183W **Description**...for submissions to FDA * Provide ongoing support to project teams for regulatory issues and questions.… more
- Ascendis Pharma (Palo Alto, CA)
- …to all aspects of the business, from drug development to marketing. The Manager, Regulatory Affairs will be responsible for supporting and developing global ... be based in Palo Alto, CA and reports directly to the Senior Director, Regulatory Affairs . Key Responsibilities + Responsible for strategic and operational … more
- Integra LifeSciences (GA)
- …challenging what's possible and making headway to help improve outcomes. The Sr. Regulatory Affairs Specialist is a seasoned senior professional role responsible ... in the US, EU, Canada and globally. The Sr. Regulatory Affairs Specialist is responsible for providing...independently or with minimal supervision. + Ability to explain regulatory requirements and pitfalls to project teams… more
- Teleflex (Morrisville, NC)
- Regulatory Affairs Specialist **Date:** Apr 16, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** ... patients' lives. **Position Summary** Under the guidance of the Manager, Strategic Regulatory Affairs , support the Strategic Manufacturing group to coordinate… more
- Teleflex (Wyomissing, PA)
- …lifecycle with effective project coordination. The position supports the Regulatory Affairs function and the organization by communicating regulatory ... * 2-5 years in a medical device organization, preferably in regulatory affairs * Previous 510(k) experience preferred * RAC certification preferred, but not… more
- System One (Deland, FL)
- Position: CONTRACTOR -- Director, US Regulatory Affairs & Global Development Projects (GDP) Location: Remote (East or Central Time Zone) / Prefers local ... Pay Rate: 80/hr - 95/hr Purpose and Scope of Position The Director, US Regulatory Affairs & Global Development Projects (GDP) is responsible for providing… more