- Robert Half Office Team (Norfolk, VA)
- …candidate has successfully spearheaded and completed at least 1 full 510 ( k ) in the (not-too-distant) past. Requirements Medical- regulatory , Regulatory ... Agencies, Regulatory Documents, Regulatory Compliance, Regulatory Filings, Regulatory Policies, Regulatory Reporting, Regulatory Reporting… more
- ICU Medical (Lake Forest, IL)
- …of medical device industry experience with a minimum of five years in regulatory affairs with direct experience with 510 ( k ) and/or CE technical files. * ... Job Title Manager, Regulatory Affairs - Electromechanical Devices FLSA...prioritize workload for self and others * Experience with 510 ( k ) submissions and obtaining clearances in their… more
- Edwards Lifesciences (Irvine, CA)
- …skills and background helping us achieve our goals:** + Experience with strong input/authoring 510 ( k )s + Regulatory affairs experience with software ... for (Preferred):** + Experience with strong input/authoring 510 ( k )s strongly preferred + Regulatory affairs experience with software devices + Experience… more
- Envista Holdings Corporation (Brea, CA)
- …adherence, regulatory compliance, scheduling, and cost objectives. + Collaborate with Regulatory Affairs on 510 ( k ) submissions, product licensing, ... and regulatory compliance goals. + Demonstrate knowledge of all product lines, including clinical features and customer requirements. + Update the Product Planning Group (PPG) regularly to ensure project status visibility, employing Daily Management (DM)… more
- Medtronic (Minneapolis, MN)
- …and clinical protocols for regulatory compliance. Work on PMA (Pre-Market Approval) or 510 ( k ) submissions for US Class III or Class II medical devices. Work ... Position Description: Sr. Regulatory Affairs Specialist for Medtronic, Inc....experience with each of the following: Pre-Market Approval or 510 ( k ) submissions for US Class III or… more
- Philips (Orlando, FL)
- **Senior Regulatory Affairs Manager (US Hub based location)** The Senior Regulatory Affairs Manager will develop and communicate a vision for the RA ... of regulatory submissions. You will manage a Regulatory Affairs team supporting various new and...submissions for new product introductions is required. Experience with 510 ( k ) submissions and class 2/2a for EU… more
- Philips (San Diego, CA)
- …Recommends strategies for earliest possible approvals of clinical trials applications. + Regulatory Affairs representative for the CT/AMI Systems and assists ... CE Marking per MDD, EU MDR (updating Technical Files), 510 ( k ) Worldwide product registrations, clinical evaluations. Post...quality system audits. + Reporting to the Director of Regulatory Affairs , the Senior RA Specialist will… more
- Medtronic (Boston, MA)
- Principal Regulatory Affairs Specialist - Surgical The Principal Regulatory Affairs Specialist will play a key role in launching new products and ... regulatory requirements and partners with the international regulatory affairs group to support regulatory...technical field such as engineering + Experience in Pre-Sub, 510 ( k ), De Novo, Technical File/Design Dossier, EU… more
- J&J Family of Companies (Columbus, OH)
- …and executes regulatory strategy for significant change supplements and 510 ( k ) registrations to support continued commercialization of products in key ... Regulatory Affairs Specialist II (Wound Closure... Regulatory Affairs Specialist II (Wound Closure & Healing) -...Johnson & Johnson MedTech, is currently recruiting for a ** Regulatory Affairs Specialist II** to support our… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …in vitro diagnostic devices with proven success in the preparation and completion of regulatory submissions (PMA, 510 ( k ), IDE, Pre-submissions) to the FDA ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the...and preparing submission related documents) + Prepare and audit 510 ( k )s, IDEs, PMA and/or international submissions as… more
- ICON Clinical Research (Farmingdale, NY)
- …IVD device submissions in the context of drugs/biologics submissions, eg, Q-Submissions, IDEs, 510 ( k )s, and in carrying out regulatory activities and ... an industry. As Regulatory Manager, you will work in Global Regulatory Affairs team, a successful and driven team that provides consultancy for all ICON… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …strategy for BDB products. + Coordinates and advises the preparation of complex regulatory submissions, including Premarket ( 510 ( k )) Notifications, de novo ... manage the performance review, hiring and firing process for Regulatory Affairs professionals under his/her direction. +...industry. + EU MDR/IVDR experience. + History of successful 510 ( k ) clearances and/or PMA approvals of in… more
- Stryker (Fremont, CA)
- …Here are 10 reasons to join our Regulatory Affairs /Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory ... visiting stryker.com We are currently seeking a **Senior Staff Regulatory Affairs Specialist** to join our Neurovascular...IDE, IDES, IDE Progress Report, Clinical Trial Submission [OUS], 510 ( k ), PMA, PMA Annual Report, HDE, HDE… more
- Medtronic (Mounds View, MN)
- Senior Regulatory Affairs Specialist - Cardiac Surgery (hybrid) Cardiac surgery represents end stage treatment in the care continuum for many cardiovascular ... technology and solutions. Careers that Change Lives The Senior Regulatory Affairs Specialist is responsible for developing...impact to US and EU requirements + Experience with 510 ( k )/IDE/PMA device product submissions and EU regulations… more
- Stryker (Allendale, NJ)
- … Affairs experience required. + Previous experience on EU MDR and drafting 510 ( k ) regulatory submissions to FDA required. + Previous experience with ... to apply? Here are 10 reasons to join our Regulatory Affairs /Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory -… more
- Teleflex (Morrisville, NC)
- Sr. Regulatory Affairs Manager - Product Management **Date:** Jun 4, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% ... that make a difference in patients' lives. **Position Summary** The Senior Manager, Regulatory Affairs is an experienced leadership position with a deep… 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...and on-site audit support. (eg, IDE's, PMA's, annual reports, 510 ( k )'s, STED's and CE marking design dossiers… 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 ensure compliance...of work experience in the field. Experience with either 510 ( k ) applications, PMA supplements and US device… more
- Kelly Services (Irvine, CA)
- ** Regulatory Affairs Specialist III (hybrid)** The...US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510 ( k ) is preferred. + Familiarity in the ... Affairs Specialist III, will provide administrative and technical support to regulatory affairs leadership in order to facilitate compliance with US and… more
- Teleflex (Wyomissing, PA)
- Sr. Regulatory Affairs Specialist **Date:** May 28, 2024 **Location:** Wyomissing, PA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... solutions that make a difference in patients' lives. **Position Summary** The Sr. Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies,… more