- Xcelerate Solutions (Frederick, MD)
- Program Analyst IV - Medical Regulatory & Acquisition Strategy Xcelerate Solutions is seeking a Senior program analyst who will support Joint Program Executive ... Office for CBRN Defense (JPEO-CBRND) Medical Regulatory and Acquisition Strategy (MRAS) team. In this role, you will support the MRAS Team of medical … more
- Abbott (Santa Clara, CA)
- …and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) Program** to be located ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- J&J Family of Companies (Titusville, NJ)
- …New Jersey, United States of America **Job Description:** **Senior Manager/Associate Director, Regulatory Medical Writing X-TA** At Johnson & Johnson Innovative ... searching for the best talent for a **Senior Manager** **/Associate Director** , ** Regulatory Medical Writing** within our Integrated Data Analytics & Reporting… more
- J&J Family of Companies (Spring House, PA)
- …at https://www.jnj.com/innovative-medicine We are searching for the best talent for a **Manager, Regulatory Medical Writing** to support one or more of our ... therapeutic areas in within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting (IDAR) business. The position may be in the UK (High… more
- Cedars-Sinai (Beverly Hills, CA)
- …Los Angeles and beyond. **Req ID** : 11799 **Working Title** : Lead Regulatory Coordinator - Medical Network **Department** : CA Heart Foundation **Business ... you ready to be a part of breakthrough research?** The Lead Regulatory Coordinator prepares and submits large and/or complex protocols and supporting documentation… more
- J&J Family of Companies (Santa Clara, CA)
- …and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Regulatory ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more
- Beth Israel Lahey Health (Woburn, MA)
- …delegation agreements between the hospitals and insurance plans. + Lead preparation for regulatory surveys and audits related to medical staff functions + ... of regulatory standards (Joint Commission, NCQA, CMS) and state/federal regulatory requirements. + Experience supporting medical staff governance, bylaws… more
- Georgetown Univerisity (Washington, DC)
- …and Director of Division of Surgical Services Research at Georgetown University Medical Center (GUMC). The Regulatory Coordinator collaborates closely with a ... a difference in the world. Requirements Job Overview The Regulatory Coordinator plays a critical role in ensuring ...(DoS) overseen by Research Director, CTTM at Georgetown University Medical Center (GUMC). Working under the direct supervision of… more
- Bausch Health (Bothell, WA)
- …Degree Required Life science or technical discipline preferred. Minimum 6 years regulatory experiences in MNC medical device company (aesthetic device is ... skills and values drive our collective progress and impact. The Manager, Regulatory Affairs will be responsible for: + Responsible for developing and implementing… more
- Stryker (Redmond, WA)
- …Monday through Wednesday in **Redmond, Washington.** **What you will do** As part of the Medical Regulatory Affairs team, you will work with the team to maintain ... We are currently seeking a **Senior Regulatory Affairs Specialist** to join our ** Medical...Regulatory Affairs) + Previous experience with Class II/III medical devices + Experience authoring regulatory submissions… more
- Caldera Medical (Westlake Village, CA)
- …Life for Women! Message from the Hiring Manager: In your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory ... submit and provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU… more
- Hologic (Louisville, CO)
- Regulatory Affairs Specialist, Medical Device Louisville, CO, United States Marlborough, MA, United States **Join Hologic's Surgical Division as a Regulatory ... medical device industry. **What You'll Bring:** **Experience** + 2-5 years in regulatory affairs, preferably within the medical device industry. + Proven… more
- Abbott (St. Paul, MN)
- …+ Minimum of 5 years' experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus. + Experience with ... device regulations and submissions. + Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and… more
- Medtronic (Irvine, CA)
- … Device Experience:** Minimum of 4 years of relevant experience in medical device regulatory affairs. + **510(k) Submission Experience:** Proven history ... advanced degree with a minimum of 2 years of experience in medical device regulatory affairs is a plus. + ** Regulatory Knowledge:** Excellent technical… more
- Terumo Aortic (Sunrise, FL)
- …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 preferred. + Preferred… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …for Surgery. This position is responsible for managing, assessing, and executing on regulatory activities for existing drug and medical device products to create ... global regulatory agencies. **Responsibilities include:** + Write drug and medical device regulatory submissions including NDA, ANDA, Prior Approval… more
- Medtronic (Santa Rosa, CA)
- …applicant profile_ + Bachelor's degree in a technical discipline + Minimum 4 years of medical device regulatory experience + Or minimum 2 years of medical ... PDP teams + Direct experience authoring and successful approval of regulatory submissions for Class IIb /III/IV medical devices in the US, Japan, or EU (eg, IDE,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …on projects in the assigned therapeutic area from the global regulatory , legislative, scientific, medical , pharmaceutical, pharmacovigilance, market access and ... + As defined by respective BI processes, review and release, via cross-functional medical legal- regulatory team, US core messages, as appropriate (eg, press… more
- West Pharmaceutical Services (Exton, PA)
- …Bachelor's with 5+ years required; or + Master's degree/PhD 2+ years medical device regulatory experience required **Preferred Knowledge, Skills and Abilities** ... Sr. Specialist, Regulatory Affairs, Product Stewardship Requisition ID: 69466 Date:...legislations (eg California Prop 65, RoHS, Conflict Minerals, EU Medical Device Regulation) for all West global product portfolios… more
- J&J Family of Companies (Palm Beach Gardens, FL)
- …relevant regulatory experience (6+ years with Master's, 5+ years with PhD); Medical Device regulatory experience _strongly preferred_ . + Experience with US ... and European medical device regulatory processes **required** . + Experience in preparing and submitting US regulatory files (510(k)s, PMAs) as well as… more