- Merck & Co. (North Wales, PA)
- …review and submit PQC reports and provide PQC data /line listings to US Regulatory Affairs for inclusion in Drug Experience Reports to be submitted to ... Job DescriptionThe Senior Specialist , Quality Management Systems and Compliance reports to... regulatory authorities including the US FDA.- -Support global manufacturing… 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
- Medtronic (Santa Rosa, CA)
- Principal Regulatory Affairs Specialist - Structural Heart and Aortic, Mitral and Tricuspid (hybrid) Come be a part of one of the most exciting therapy areas ... Affairs team and looking to hire a Principal Regulatory Affairs Specialist to make...Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions,… 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
- 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 ... recruiting for a ** Regulatory Affairs Specialist II** to support Life Cycle Management and New Product Development. _This role will work a Hybrid/Flex… more
- J&J Family of Companies (Columbus, OH)
- Senior Regulatory Affairs Specialist - 2406173183W **Description** Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory ... has a proven track record for growth, integrity and innovation. The Senior Regulatory Affairs Specialist will be responsible for developing strategies… 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
- 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
- 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
- Kelly Services (Rochester, NY)
- …you find a job that works for you. How about this one? We're seeking a Regulatory Affairs - Specialist Global Labeling Lead Medical Devices to work at ... on experience. Why you should apply to be a Regulatory Affairs - Specialist Global...we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource… more
- Healgen Scientific Limited (Houston, TX)
- Regulatory Affairs Specialist Regulatory Affairs | Houston, TX Apply Now (upload_80.html) Back to Search Join us on our exciting journey! Healgen ... flow cytometry. About the role The purpose of a Regulatory Affairs Specialist is to...approve Healgen and private brand labeling. Create and submit applications for medical device registration, private label requests, and… more
- Philips (Colorado Springs, CO)
- The Principal Regulatory Affairs Specialist will play a critical role in ensuring our Coronary Vascular products are safe, reliable, and compliant with ... Team to set and deliver the objectives. Mentor other regulatory affairs personnel within IGTD Regulatory... regulatory affairs personnel within IGTD Regulatory . + Communicate application progress to internal… 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
- Actalent (Littleton, MA)
- Description: The Regulatory Affairs Specialist is responsible for identifying, evaluating, and ensuring compliance with all applicable laws, regulations, and ... standards. The Regulatory Affairs Specialist shall also...and submission materials. * Submit Establishment and Device registration applications . Prepare IDE, 510(k), PMA, CE Mark, and other… 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 (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
- Philips (San Diego, CA)
- …department operations. **Your role:** With supervision from more senior level colleagues, a Regulatory Affairs Specialist is responsible for: + Preparing ... document). (2) Support CAPAs and related time-sensitive compliance efforts for Regulatory department. (3) Support international regulatory team on efforts… more
