- Teleflex (Morrisville, NC)
- …in a science or engineering field, or equivalent work experience. - 5+ years of Medical Device Regulatory Affairs experience, domestic and international. ... Senior Regulatory Affairs Specialist **Date:** Nov 3,...- The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose… more
- Terumo Medical Corporation (Somerset, NJ)
- …assigned clinical reports, documents and scientific presentations in cooperation with the Clinical, Medical , & Regulatory Affairs Teams, Key Opinion Leaders ... include Clinical Affairs , Professional & Clinical Education, Regulatory Affairs , Quality Systems, Marketing, Sales as...a medical writer for pharmaceutical, CRO, or medical device clients, a strong plus. **Nearest… more
- embecta (Parsippany, NJ)
- …discipline (eg engineering, bioengineering, biology, chemistry). + 5+ years Regulatory Affairs experience in medical device companies. + Must have ... in both the US and Europe, and related regulatory affairs activities to ensure compliance with...current knowledge of the US and European Medical Device regulations. + Demonstrated success in… more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director, Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device ...externally with a solid background in medical devices /diagnostic development regulations and associated regulatory deliverables.… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Minimum of 10 years of Regulatory Affairs experience, ideally within the medical device or digital health industries. + Minimum of 3 years focused on ... medical devices . This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class regulatory strategies for digital… more
- Olympus Corporation of the Americas (Westborough, MA)
- …in engineering or life sciences required. + Minimum of 7 years prior regulatory affairs experience in the medical device industry, or a minimum of 5 ... to the digital transformation in the medical device space. The role focuses on executing regulatory...sensitivity to cultural differences. + Familiarity with digital health regulatory frameworks for medical devices … more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ BS or comparable required. + Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device or digital health industries. + ... solutions, including Artificial Intelligence (AI) exempt from the medical device classification, and connected technologies. + Provide regulatory guidance,… more
- Terumo Neuro (Aliso Viejo, CA)
- **13011BR** **Title:** Principal, Regulatory Affairs **Job Description:** Responsible for establishing, preparing, and leading the strategy for worldwide product ... solutions. + Coach, review, and delegate work to junior regulatory affairs professionals; may manage large projects...by multiple successful US FDA Class II / III medical device submissions, EU CE Mark applications,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …closely with cross-functional teams, including sales, marketing, medical affairs , market access and policy/advocacy (MAPA), regulatory affairs ... Nordisk's Rare Disease portfolio. The Rare Disease portfolio includes medical treatments, customer solutions, and devices across...drive market share and revenue growth. Partner with legal, regulatory , and medical affairs for… more
- embecta (Parsippany, NJ)
- …changes, internal audits, or process improvements. + Ensure documentation adheres to global medical device regulatory requirements, including FDA 21 CFR Part ... workflows to enhance efficiency and compliance. + Collaborate with Quality, Manufacturing, Marketing, Medical Affairs , R&D, and Regulatory Affairs teams… more
- Teleflex (Minneapolis, MN)
- …Cardiology environment. - Medical Device industry supporting Clinical and Medical Affairs , strongly preferred. - Proficient in Microsoft Word, Excel, and ... -** The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose...System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory … more
- Organon & Co. (Jersey City, NJ)
- …years of industry experience? in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + ... leading the development or life-cycle management of drugs or devices which improve human health. The program manager may...plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical ,… more
- Teleflex (Morrisville, NC)
- …collaboration with Marketing Communications (MarCom), Product Marketing, Clinical and Medical Affairs , Legal/Compliance, Regulatory , and other ... We equip clinicians with some of the most advanced medical devices on the market today, from...- Marketing Directors - Marketing Communications - Clinical and Medical Affairs - Legal - Regulatory… more
- Terumo Medical Corporation (Somerset, NJ)
- …product and scientific support for the organization that includes Medical Affairs , Clinical Operations, Sales, Marketing, Regulatory Affairs , to ensure ... therapeutic area, provide support in the following ways: + Medical affairs strategy: + Contribute to the...+ Regulatory activities partnership: + Work with regulatory affairs to ensure that all written… more
- GRAIL (Durham, NC)
- …management system (QMS). This role's focus is on the in vitro diagnostic medical device processes, supporting the clinical laboratory processes as needed with ... not limited to all-Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs , Compliance, ProgramManagement, ClinicalAffairs, Supply Chain,… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... regulatory activities/submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience in working… more
- ITG Brands (Greensboro, NC)
- …US jurisdiction. + Minimum of 10 years of legal experience, in a highly regulatory industry (tobacco, pharmaceuticals, medical devices ). + Strong background ... responses, including strategy, redactions, and risk mitigation. Partner with Quality and Regulatory Affairs teams to support consumer complaint intake, quality… more
- Olympus Corporation of the Americas (Westborough, MA)
- …subject matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the Olympus SDLC, ... projects as required by the SDLC and will support Regulatory Affairs ' efforts in creating submission materials...on regulations around health software development, and software for medical devices . + Collaborate on the update… more
- Novo Nordisk Inc. (Charlotte, NC)
- …Incumbents have a deep scientific and clinical education and experience. Within Field Medical Affairs , this position functions as a scientific liaison between ... About the Department The Clinical, Medical and Regulatory (CMR) department at...to deliver scientific value proposition of NNI's products and devices to key customers and formulary decision makers. Delivers… more
- Terumo Medical Corporation (Elkton, MD)
- …(TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for ... of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in...+ Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21… more
