- Calyxo (Pleasanton, CA)
- …team working in a fun, diverse atmosphere. Summary: As a key member of the Regulatory Affairs team, you will play a vital role in ensuring compliance with ... Arena etc. required. Who You Will Report To: Director, Regulatory Affairs Requirements: 5+ years of ...the medical device industry, including electromechanical medical devices, Class II or Class III medical devices. Proven success with… more
- Abbott (Sylmar, CA)
- …for diversity, working mothers, female executives, and scientists. The Opportunity The Labeling Specialist II position works out of our Sylmar, CAlocation in the ... medical device products. Coordinates with Engineering, Marketing, Clinical Research, and Regulatory Affairs to define product labeling requirements. Designs and… more
- Globus Medical (Audubon, PA)
- …so patients can resume their lives as quickly as possible. Position Summary: The Regulatory Affairs Specialist assists with drafting, submitting and gaining ... to the Food and Drug Administration (FDA) for class II and class III products. This position entails development...is a plus Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry,… 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 ... etc.), math, engineering, or medical fields. + Master's degree in Regulatory Affairs . + Regulatory experience with capital equipment including software,… more
- Abbott (St. Paul, MN)
- …a best place to work for diversity, working mothers, female executives, and scientists This ** Regulatory Affairs Specialist II ** will work on-site at our ... + 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
- Zimmer Biomet (Englewood, CO)
- …valued, and have a strong sense of belonging. **What You Can Expect** The Sr. Regulatory Affairs Specialist serves as the lead regulatory representative ... teams supporting product lifecycle management activities. Responsibilities include developing regulatory strategies, reviewing design input/output documentation, identification of applicable… more
- Actalent (Irvine, CA)
- Regulatory Affairs Specialist II Job Description The Regulatory Affairs Specialist II plays a pivotal role in ensuring that the company's ... changes and provide tech file support. Essential Skills + Proficiency in regulatory affairs , especially in medical devices. + Experience in regulatory … more
- Medtronic (Santa Rosa, CA)
- …and solutions. This role will be based in Santa Rosa, CA. The **Principal Regulatory Affairs Specialist ** will support Research and Development programs with ... global regulation and guidance updates in the digital health space. Additionally, the Principal Regulatory Affairs Specialist is expected to play a key role… more
- J&J Family of Companies (Santa Clara, CA)
- …States of America **Job Description:** Johnson & Johnson is hiring for a **Sr Regulatory Affairs Specialist , Ads/Promo Global - Shockwave** to join our ... the treatment of calcified plaque. **Position Overview** The Senior Regulatory Affairs Specialist assisting with...math, engineering, medical or other technical fields and Class II /III medical device experience is preferred. + Minimum 1-2… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... to support business needs in a very timely and accurate manner. **_Sr Reg Affairs Specialist I_** **Primary responsibilities for role:** + Act as Regulatory… more
- Medtronic (Minneapolis, MN)
- …to engineer the extraordinary. This role will be based in Plymouth, MN The ** Regulatory Affairs Specialist ** is responsible for developing regulatory ... international submissions and obtaining and maintaining approval for products. Additionally, the Regulatory Affairs Specialist is responsible for assessment… more
- Abbott (Plymouth, MN)
- …get on with their lives. **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist ** to join Abbott's Electrophysiology Division on-site ... Paul, MN. 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
- Cook Medical (Bloomington, IN)
- Overview The Senior Regulatory Affairs Specialist responsible for the planning and preparation of submissions to obtain regulatory approvals for new and ... and IV medical devices in specific markets. In addition to submissions, the Regulatory Affairs Specialist will serve as a communication liaison between the… more
- Stryker (Redmond, WA)
- We are currently seeking a **Senior Regulatory Affairs Specialist ** to join our **Medical** **Division** to be based **Hybrid** Monday through Wednesday in ... certification or Advanced Degree (Masters in Regulatory Affairs ) + Previous experience with Class II /III... Affairs ) + Previous experience with Class II /III medical devices + Experience authoring regulatory … more
- Terumo Neuro (Aliso Viejo, CA)
- **12814BR** **Title:** Sr. Specialist , Regulatory Affairs **Job Description:** Responsible for preparing strategy for worldwide product approval submission ... writing skills as evidenced by successful US FDA Class II / III medical device submissions, EU CE Mark...to comprehend technical documents and concepts. **External-Facing Title:** Sr Specialist , Regulatory Affairs **Posting Country:**… more
- Abbott (Plymouth, MN)
- …on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced **Senior Regulatory Affairs Specialist ** to join our team on-site in ... Plymouth, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory … more
- Abbott (Alameda, CA)
- …working with Class II , Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. . Experience with 510(k) ... glucose levels with our new sensing technology. The Opportunity The Principal RA Specialist -Business Partnerships will work on-site out of our Alameda, CA location… more
- Abbott (Alameda, CA)
- …working with Class II , Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. + Experience with either ... glucose levels with our new sensing technology. **The Opportunity** The **Principal RA Specialist - US New Product Introduction** will work on-site out of our… more
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... domestic and international regulatory environments. Working in...understanding of global regulations relevant to medical devices, Class II and/or Class III devices + Full knowledge and… more
- Veterans Affairs, Veterans Health Administration (Louisville, KY)
- …Kentucky is currently recruiting for a Registered Nurse-Nurse Training Specialist Louisville, Kentucky 603. Responsibilities The Registered Nurse (RN) Training ... Specialist executes position responsibilities that demonstrate leadership, experience, and...a facility, Veterans Integrated Systems Network (VISN), or Veterans Affairs Central Office (VACO). Program is defined as a… more
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