- Boston Scientific (Maple Grove, MN)
- …line and pipeline, and we will continue to make an investment in Interventional treatments. This Regulatory Affairs Specialist II role will be a part of ... the Interventional Cardiology Regulatory Affairs team and will be supporting regulatory submission activities to obtain and maintain regulatory approvals… more
- Katalyst HealthCares and Life Sciences (Alameda, CA)
- Responsibilities: Responsibilities include developing regulatory strategies, reviewing design input/output documentation, identification of applicable standards and ... guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining … more
- Boston Scientific (Marlborough, MA)
- …than 50 percent of all urology surgical procedures. This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance ... in a scientific or technical discipline A minimum of 1 year work experience in Regulatory Affairs or 2 years work experience in a related discipline (eg, R&D,… more
- Boston Scientific (Maple Grove, MN)
- …required Required qualifications: Minimum of a Bachelor's Degree 7+ years of experience in Regulatory Affairs , or 5+ years of experience with an advanced degree ... continuous improvement efforts Develops domestic and international strategies for regulatory approval of Class II and III...international strategies for regulatory approval of Class II and III medical devices. This includes strategies for… more
- Smith & Nephew (Pittsburgh, PA)
- …or RA Master's degree a plus 8+ years experience in Regulatory Affairs Experience with a Class II devices Knowledge and practical application of ... Principal Regulatory Specialist , Robotics (Pittsburgh, PA) Life...the US and EU markets. You act as the Regulatory Affairs (RA) lead and subject matter… more
- Cynet Systems (Irvine, CA)
- Job Description: Pay Range: $44.60hr - 49.60hr Responsibilities: Create regulatory submissions (exercising judgment to protect proprietary information) for ... track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions. Participate in providing guidance on… more
- Bausch Health (Bothell, WA)
- Manager, Regulatory Affairs Medical Device-Aesthetics (Bothell, WA) 1 of 2 Job Location: Bothell, Washington, USA Job Requisition ID: 13600 Join our global ... your skills and values drive our collective progress and impact. The Manager, Regulatory Affairs will be responsible for: Responsible for developing 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
- Stryker (Weston, FL)
- …per week in Mahwah, NJ or Weston, FL. **What you will do** As the **Senior Regulatory Affairs Specialist ** , you will support Stryker's Mako and Enabling ... We are seeking a **Senior Regulatory Specialist ** to join our Mako...certification or Advanced Degree (Masters in Regulatory Affairs ) + Previous experience with Class II /III… more
