- Merck & Co. (Rahway, NJ)
- Job DescriptionThe regulatory operations senior specialist supports cross-functional or departmental projects related to regulatory operations . This ... of regulatory operations activities. Perform regulatory tasks in Veeva system (Alexx Submissions ,...guidelines, and industry standards related to regulatory operations .Experience in managing regulatory submissions … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJOB DESCRIPTION SUMMARYThe Clinical Operations Associate Specialist will coordinate and execute back-office and administrative tasks that support ... and overall administrative support in the Clinical Research department.The Clinical Operations Associate Specialist serves an integral function within the… more
- J&J Family of Companies (Santa Clara, CA)
- …Minnesota, United States **Job Description:** Johnson & Johnson is hiring for a **Sr Regulatory Operations Specialist - Shockwave Medical** to join our team ... pressure waves for the treatment of calcified plaque. **Position Overview** The Senior Regulatory Operations Specialist is an individual contributor who will… more
- Integra LifeSciences (Braintree, MA)
- … regulatory strategies, and revise technical documentation for existing and new regulatory submissions . + Lead in the development of US and International ... and making headway to help improve outcomes. The Sr. Regulatory Affairs Specialist is a seasoned senior...(510k, PMA, BLA) with minimal supervision. Ensure timeliness of regulatory submissions according to business needs. This… more
- Kelly Services (Valencia, CA)
- …in Valencia, CA, with occasional work in Burbank. If you have expertise in regulatory submissions and quality operations in the medical device sector, ... Valencia, CA** Kelly(R) Science & Clinical is seeking a Regulatory Specialist for a temporary, long-term position...the DQO in maintaining Quality Operations and Regulatory Program. + Handle regulatory submissions… more
- Bausch Health (Bothell, WA)
- …and responsibilities for this position title._ The Sr. Regulatory Affairs Specialist provides direct support to Solta operations for their globally ... Provides regulatory expertise to the R&D and Operations teams, including labeling requirements and submissions ...field. + Should have 3-5 years' experience as a Regulatory Affairs Specialist and/or Sr. Regulatory… more
- UPMC (Pittsburgh, PA)
- …of cancer. UPMC Hillman Cancer Center is currently hiring a regular full-time Regulatory Specialist to help support the Women's Oncology Clinical Research ... Disease Center program study working Monday through Friday daylight hours. The Regulatory Specialist 's purpose is to develop regulatory forms/documents… more
- Merck (Rahway, NJ)
- **Job Description** The regulatory operations senior specialist supports cross-functional or departmental projects related to regulatory operations . ... of regulatory operations activities. Perform regulatory tasks in Veeva system (Alexx Submissions ,...regulatory operations . + Experience in managing regulatory submissions and document management systems. +… more
- J&J Family of Companies (Santa Clara, CA)
- …In collaboration with cross-functional team members, compile, prepare, review and submit high-quality regulatory submissions to authorities on time in US and EU. ... Description:** Johnson & Johnson is hiring for a **Sr.** ** Regulatory Affairs Specialist (Remote) - Shockwave Medical**...Support international regulatory team with submissions to other geographies… more
- Teleflex (Chelmsford, MA)
- Sr. Regulatory Affairs Specialist **Date:** Mar 11, 2025 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... a difference in patients' lives. **Position Summary** The Sr. Regulatory Affairs Specialist (SRA) will develop US,...will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to… more
- West Pharmaceutical Services (Exton, PA)
- …software and regulatory tools. + Proven track record of successful regulatory submissions and interactions with regulatory authorities. + Experience ... Sr. Specialist , Regulatory Project Management (Evergreen Posting)...regulatory team through all project phases to support submissions including Premarket Notifications, Technical Documentations under EU MDR… more
- Abbott (Sylmar, CA)
- …compliance with applicable regulations. + Reviews protocols and reports to support regulatory submissions . + Supports all business segment initiatives as ... contractors, and vendors. + Provides mentoring and leadership to Regulatory Specialist I and II team members....with EU and other international medical device regulations and submissions . + 2-3 years of experience in regulatory… more
- Amazon (Lockbourne, OH)
- … regulatory strategies for new and modified products. * Prepares and submits regulatory submissions to health agencies. * Interprets new or existing ... the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to...and vendors. * Reviews protocols and reports to support regulatory submissions . * Creates, reviews and approves… more
- Medtronic (Minneapolis, MN)
- …requirements + Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and ... compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible...standards + Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements… more
- J&J Family of Companies (Santa Clara, CA)
- …+ In collaboration with cross-functional team members, compile, prepare, review and/or submit regulatory submissions to authorities in and outside the US, as ... of America **Job Description:** Johnson & Johnson is hiring for a **Principal** ** Regulatory Affairs Specialist (Remote) - Shockwave Medical** to join our team… more
- J&J Family of Companies (Santa Clara, CA)
- …met. **Essential Job Functions** * Assist with compiling, preparing, reviewing and submitting regulatory submissions to authorities in and outside the US (eg, ... United States of America **Job Description:** Johnson & Johnson is hiring for a ** Regulatory Affairs Specialist (Remote) - Shockwave Medical** to join our team… more
- Abbott (Alameda, CA)
- …to substantiate claims. You may also have opportunities to participate in worldwide regulatory submissions . This is a broad scoped position with strong ... with our new sensing technology. **The Opportunity** This **Senior Regulatory Affairs Specialist ** will work out of...NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed. + Determine… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …MMS-PA products to MMS-PA collaborators + Coordinates and advises the preparation of regulatory submissions , including EU Technical Files for CE mark (Machinery ... development protocols to assure collection of appropriate data for product release, regulatory submissions and regulatory compliance + Coordinates with… more
- Abbott (Plymouth, MN)
- …and get on with their lives. **The Opportunity** We are recruiting for a **Senior Regulatory Affairs Specialist ** to join our team on-site in our St. Paul or ... with applicable regulations. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Supports all business segment initiatives… more
- Abbott (Sylmar, CA)
- …requests for product release. + Reviews protocols and reports to support regulatory submissions . + Supports all business segment initiatives as identified ... arrhythmias, or irregular heartbeats. **The Opportunity** We are presently hiring for a ** Regulatory Affairs Specialist II** to work on-site at our Cardiac… more
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