- Merck & Co. (South San Francisco, CA)
- …to enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions .The candidate will play a key role in developing, ... ability to influence scientists to adapt to positive change. -Experience with regulatory submissions and understanding of the review process. -Familiarity with… more
- Aequor (Thousand Oaks, CA)
- …work alongside other innovative, driven professionals in this meaningful role. Role: Specialist Manufacturing, New Product Introduction Let's do this! At we strive ... for the introduction of new products into the manufacturing plant. This " Specialist Manufacturing" role will serve as a New Product Introduction Lead within… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- …follow-up of submissions under review. Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM ... for submissions . Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation. Reviews… more
- Intuitive (Sunnyvale, CA)
- …communication skills, proven ability to translate technical documentation into effective regulatory submissions . Good interpersonal skills and able to work ... experience is required. Minimum 4 years of working experience supporting international submissions preferred; Previous China regulatory affairs experience is a… more
- Katalyst HealthCares and Life Sciences (Pleasanton, CA)
- …assists in creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change ... development teams and commercial support with guidance. Participates in preparing regulatory strategies. Reviews submissions , regulatory commitments,… more
- Cleerly (Denver, CO)
- …States and account for geography when determining base salary. Responsibilities (General) Regulatory Submissions & Liaison: Prepare, review, and complete ... regulatory submissions to global regulatory agencies (eg, FDA,... compliance issues. Mentorship & Development: Mentor and develop senior regulatory professionals, guiding them through complex… more
- Cincinnati Children's (Burnet, TX)
- …of research regulations, ethics and guidelines, analyze research protocols submissions (new protocols, continuing review, changes to protocols, one-time use ... SAE reports, and continuing reviews. Complete all reviews and submissions in a timely manner, meeting all deadlines. Under...timely manner, meeting all deadlines. Under the guidance of senior staff, may assist in the development of protocol… more
- Aditi Consulting (Newbury Park, CA)
- …Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team. Engaging with Quality and Regulatory teams to ... of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills.… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …products. + Prepare responses to regulatory agency inquiries. + Compile regulatory submissions through coordination with other departments and research of ... a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for...a very timely and accurate manner. **_Sr Reg Affairs Specialist I_** **Primary responsibilities for role:** + Act as… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance ... for 510(k) submissions , and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist , Regulatory Affairs...of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, ... including Premarket Notifications and Technical Documentation for CE Marking. The Senior Specialist ensures timely and high-quality execution of all… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This ** Senior Regulatory Affairs Specialist ** position is an onsite ... Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is...for submission filing. + Compile, prepare, review and submit regulatory submissions to authorities. + Monitor impact… 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 ... III and IV medical devices in specific markets. In addition to submissions , the Regulatory Affairs Specialist will serve as a communication liaison between… more
- Hologic (Marlborough, MA)
- Senior Regulatory Affairs Specialist Newark, DE, United States Marlborough, MA, United States **Join us as a Regulatory Affairs Specialist ... with R&D, Quality, Clinical, and Marketing, you will prepare and manage regulatory submissions , technical files, and documentation to meet US, EU, and Canadian… 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 ... and compliance requirements (local, national, international) + Prepare and submit regulatory submissions (electronic and paper) in accordance with applicable… more
- Abbott (Plymouth, MN)
- …get on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Senior Regulatory Affairs Specialist ** to join our team on-site in ... affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory… more
- Danaher Corporation (New York, NY)
- …Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Regulatory Affairs Specialist I ... for for pre-market regulatory affairs activities. The Senior Regulatory Affairs Specialist I...have the opportunity to: + Develop and execute global regulatory strategies, including FDA 510(k), Pre- Submissions , Health… more
- Medtronic (North Haven, CT)
- …assigned. + Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and ... **A Day in the Life** 1) Review promotional material. 2) Perform regulatory evaluation of the change development project/engineering change orders. 3) Responsible… more
- Edwards Lifesciences (Irvine, CA)
- … submissions . Track timelines and documents milestone achievements for inclusion in regulatory submissions . May interact with regulatory agencies as part ... difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and… more
- Caldera Medical (Westlake Village, CA)
- Senior Regulatory Specialist Located in Westlake Village, CA; Onsite - No remote option. Caldera Medical's Mission - To Improve the Quality of Life for ... Women! In your role as a Sr. Regulatory specialist , you will develop and implement...worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on… more
