- Abbott (Alameda, CA)
- …to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Specialist II - APAC** will work ... team goals and division regulatory priorities. + Provides support to Regulatory Affairs management when working towards resolution of compliance issues,… 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 ... is preferred. + Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Proficient with MS Office suite (Word, Excel, Outlook)… more
- Abbott (Pleasanton, CA)
- …a best place to work for diversity, working mothers, female executives, and scientists. This ** Regulatory Affairs Specialist ** ** II ** will work out of ... + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society Certification is a...in the Medical Device industry. + Regulatory Affairs Professionals Society Certification is a plus. Apply Now… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Regulatory Affairs Specialist II , you will be responsible for the implementation of strategies including domestic and ... compliance or quality systems; or a combination of equivalent.education and experience + Regulatory Affairs Certification (RAC) desired For certain roles at BD,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …on labeling and labeling requirements. **Primary Responsibilities:** + Act as Regulatory Affairs authority for specified key products/facilities/equipment with a ... local laws** Learn more about Grifols (https://www.grifols.com/en/what-we-do) **Req ID:** 514654 **Type:** Regular Full-Time **Job Category:** Regulatory Affairs more
- Actalent (Sharonville, OH)
- …meeting customer expectations. - Work to provide solutions, rather than just answers. Skills: Regulatory , Regulatory affairs , Fda, Regulatory documents, ... Description: The role of the Quality Specialist is to provide regulatory support...dietary supplements, regulatory systems Top Skills Details: Regulatory , Regulatory affairs ,Fda, Regulatory documents,… more
- ThermoFisher Scientific (Florence, SC)
- …years meaningful experience. **Experience:** Prefer 2 years direct experience in regulatory affairs /Quality Assurance, analytical r&D, or quality control ... document and maintain the company's Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Materials & Reagents Center of Excellence, Quality Compliance, Supply Chain, and Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls). This person ... experienced professional will provide product quality support that focuses on regulatory writing of BLA sections for Kite's fast-moving clinical programs. This… more
- Gilead Sciences, Inc. (Foster City, CA)
- …such as Formulation and Process Development, Manufacturing, Engineering, Packaging, and Regulatory Affairs to ensure that Clinical/Commercial Drug Products are ... a wide variety of activities to ensure compliance with applicable regulatory requirements. + Participates in developing Standard Operating Procedures (SOPs) to… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …a relatively small trial portfolio. KEY RESPONSIBILITIES: + Assists regulatory team ( Regulatory Specialist II and III) in research efforts by ... Specialist I is an entry-level position supporting regulatory affairs in clinical trial research. The...entities. + Supports the Assistant Director, Operations Manager, and Regulatory Coordinators II /III in Program Research in… more
- Cook Medical (Pittsburgh, PA)
- …motivated by helping others, and driven by integrity, we invite you to apply. The Regulatory Publishing Specialist II at Cook MyoSite, Inc. is responsible in ... in any Life Sciences, or 2-4 years of direct, relevant experience in Regulatory Affairs publishing to provide a comparable background * Minimum of 2-4 years of… more
- Stryker (Allendale, NJ)
- …information is available at www.stryker.com We are currently seeking a **Senior Staff Regulatory Affairs Specialist ** to join our **Spine Division** based ... expectations. **What you will do** As the Senior Staff Regulatory Affairs Specialist , you will...II /III medical devices required. + Experience interacting with regulatory agencies required. + RAC certification or Advanced Degree… more
- Stryker (Cary, IL)
- …More information is available at www.stryker.com We are currently seeking a **Staff Regulatory Affairs Specialist ** to join our **Medical Division** . ... leadership teams. **What you will do** As the **Staff Regulatory Affairs Specialist ** , you...Affairs role required. + Previous experience with Class II /III medical devices preferred. + Previous experience drafting 510(k)s… more
- Stryker (Cary, IL)
- …is available at www.stryker.com We are currently seeking a **Staff International Regulatory Affairs Specialist ** to join our **Medical** **Division** ... and meets regulations and expectations. **What you will do** As the **Staff International** ** Regulatory Affairs Specialist ** , you will develop and apply… more
- Teleflex (Wyomissing, PA)
- Sr. Regulatory Affairs Specialist **Date:** May 28, 2024 **Location:** Wyomissing, PA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... a difference in patients' lives. **Position Summary** The Sr. Regulatory Affairs Specialist (SRA) will...communicate to internal stakeholders. * Brings Regulatory Affairs questions/issues to the attention of RA … more
- Medtronic (Northridge, CA)
- …90,000+ employees in more than 160 countries. **A Day in the Life** As Principal Regulatory Affairs Specialist , you will develop and implement medical device ... external networks. In this role, you will have primary RA responsibility for multiple Class II (IIa/IIb)... agencies. + As an individual contributor, the Principal Regulatory Affairs Specialist is responsible… more
- Edwards Lifesciences (Irvine, CA)
- …maintaining regular, in-person collaboration. **How you'll make an impact:** As a Senior Specialist , Regulatory Affairs , you work with other functional areas ... patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative...understanding of domestic and global regulations relevant to Class II and/or Class III medical devices Aligning our overall… more
- Medtronic (Minneapolis, MN)
- Position Description: Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing ... or 510(k) submissions for US Class III or Class II medical devices. Work on MDD (Medical Device Directive)...closely related field and 2 years' experience as a Regulatory Affairs Specialist , R&D Engineer… 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...Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus.… more
- Actalent (Laguna Hills, CA)
- Description: This position is a regulatory affairs specialist for a medical device company. Individual must be knowledgeable in medical device industry and ... have Class II or Class III device experience. Candidate will: Prepare...maintain Adagio compliance. Post-market and vigilance reporting process. Represent Regulatory Affairs on Engineering & R&D product… more