- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...areas as needed Advise stakeholders of submission completion Compile applications and prepare for sign-off (INDs/NDAs/BLAs/510ks, IND amendments &… more
- Merck & Co. (South San Francisco, CA)
- …reports. Interact with colleagues from multiple areas, including discovery, regulatory affairs , project teams, and development functions.Partner with ... DescriptionJob Responsibilities:Primary responsibility is writing and preparing nonclinical pharmacology regulatory document submission sections and study reports to support… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …of improving the health of our communities. About the Role:Job SummaryThe Research Regulatory Specialist performs a wide range of tasks essential to the ... other certifications:Preferred Educational Requirements: Preferred Experience: Specialized training/certification in Regulatory Affairs or Clinical Research.Other: Job Specific… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Regulatory Affairs Specialist (Remote Eligible)(Abramson Cancer Center) Job ... Profile Title Regulatory Affairs Specialist Job Description Summary The Abramson...to facilitate the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …manage Annual Reports and other duties as needed. **Primary responsibilities for the Regulatory Affairs Specialist role:** + Manages dossier compilation for ... of related technical and/or regulatory experience in biopharmaceutical industry. **_Sr. Regulatory Affairs Specialist I_** + Bachelor's degree in… more
- Hologic (Newark, DE)
- Regulatory Affairs Specialist Newark, DE, United States Hologic is seeking a ** Regulatory Affairs Specialist ** to join our expanding Innovation ... Center located in Newark, DE. **What to Expect:** The ** Regulatory Affairs Specialist ** is expected...and interpersonal skills. + Excellent ability to use technology applications such as MS Office + Knowledge of document… more
- Abbott (Alameda, CA)
- …levels with our new sensing technology. **The Opportunity** We are presently hiring for a ** Regulatory Affairs Specialist ,** as part of the Regulatory ... CA. As an individual contributor, the function of a Regulatory Affairs Specialist is to...Determine and communicate submission and approval requirements. + Monitor applications under regulatory review. + Evaluate proposed… more
- Randstad US (Cambridge, MA)
- regulatory affairs specialist (cambridge). + cambridge , massachusetts + posted 5 days ago **job details** summary + $65 - $80 per hour + contract + bachelor ... core member of multiple new product development teams, the Regulatory Affairs Specialist will provide...or other unique characteristics of the project. Additionally, the Regulatory Specialist will: + Communicate application… more
- Kelly Services (Irvine, CA)
- ** Regulatory Affairs Specialist ** The Regulatory Affairs Specialist II, will provide administrative and technical support to regulatory ... with US and international regulatory requirements. The Regulatory Affairs Specialist provides direct...to ensure right product/right country. + Requires use and application of Regulatory concepts, practices and techniques.… more
- Philips (Pittsburgh, PA)
- **Principal Regulatory Affairs Specialist , Software (US Hub based)** Clinical Integration and Insight (CII) is changing the way healthcare is delivered at ... (CII) business unit._ + _Lead project teams for end-to-end Regulatory Affairs input and deliverables for new...of 1990, applicants that require accommodation in the job application process may contact ###, option 5, for assistance.… more
- Stryker (Cary, IL)
- …annually. More information is available at www.stryker.com We are currently seeking a ** Regulatory Affairs Specialist ** to join our **Medical Division** . ... and leadership teams. **What you will do** As the ** Regulatory Affairs Specialist ** , you...and author registrations, amendments, and supplements to product marketing applications . + Provide regulatory guidance to other… more
- Medtronic (Miami Lakes, FL)
- Senior Regulatory Affairs Specialist - Mechanical Circulatory Support (hybrid) Join a diverse team of innovators who bring their worldview, their unique ... leader in medical technology and solutions. Careers That Change Lives The Senior Regulatory Affairs Specialist (Sr. RAS)develops and executes strategies for… more
- J&J Family of Companies (Irvine, CA)
- Sr Regulatory Affairs Specialist - 2406185151W **Description** Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation ... a member of the Johnson & Johnson Family of Companies, is currently seeking a Senior Regulatory Affairs Specialist to be based in Jacksonville, FL or Irvine,… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist ** to join Abbott's Heart Failure ... Pleasanton, CA. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to...approval of new and modified products. + Prepares robust regulatory applications for FDA and/or international … more
- Teleflex (Maple Grove, MN)
- Sr. Regulatory Affairs Specialist **Date:** Apr 13, 2024 **Location:** Maple Grove, MN, US **Company:** Teleflex **Expected Travel** : None **Requisition ... solutions that make a difference in patients' lives. **Position Summary** The Regulatory Affairs Specialist will develop strategies and submissions… more
- Abbott (Atlanta, GA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist ** to join Abbott's Heart Failure ... Division. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible...to compile and submit international product registrations and licensing applications . + Interprets new or existing regulatory … more
- Abbott (Alameda, CA)
- …help Abbott shape the future of healthcare. As an individual contributor, the **Senior Regulatory Affairs Specialist ** will support product development and ... This is an exciting opportunity at Lingo. **What You'll Work On** + Represent Regulatory Affairs on cross functional project teams and provide strategic input… more
- Abbott (Plymouth, MN)
- …and get on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Regulatory Affairs Specialist II** to join our team on-site in ... You'll Work On** + Assists in the preparation of regulatory applications (including annual reports) to achieve...Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Proficient with… more
- Abbott (Pleasanton, CA)
- …best place to work for diversity, working mothers, female executives, and scientists. This ** Regulatory Affairs Specialist ** **II** will work out of our ... market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for...+ Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society Certification is a… more
- Kelly Services (Cuyahoga Falls, OH)
- Kelly Science & Clinical is seeking a **Senior Regulatory Affairs Specialist near Cuyahoga Falls, OH.** **Direct Hire** **Shift:** Monday - Friday 8am-5pm ... technology field + 5+ years of progressive experience in regulatory affairs required + Appropriate combination of...we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource… more
