- 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 ... values drive our collective progress and impact. The Manager, Regulatory Affairs will be responsible for: Responsible...Life science or technical discipline preferred. *Minimum 6 years' regulatory experiences in MNC medical device… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global ... Regulatory Affairs and Clinical Safety (GRACS) function...including drug device /combination products and software as medical device platforms.- Reviews and resolves issues… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …failures.Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)ICF reviews to ensure adequate disclosure for ... retention, testing and retesting of samplesProject Team Participation: Provide device -specific regulatory insight/guidance during CDx Indication Team Working… more
- Conmed (Denver, CO)
- …in scientific or technical disciple. Experience : 5+ years of Regulatory Affairs experience ( Medical device industry preferred). Regulatory working ... Job Summary: The Sr. Regulatory Affairs Specialist plays a critical...Page for more information. Competitive compensation Excellent healthcare including medical , dental, vision and prescription coverage Short & long… more
- BioTalent (Carlsbad, CA)
- …Qualifications: Bachelor's degree with a minimum of 5 years of Regulatory Affairs experience in the medical device industry. Hands-on experience with ... Join a leading medical device company in beautiful North...beautiful North San Diego! We're seeking an experienced Senior Regulatory Affairs Specialist to support global … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Engagement, Medical Affairs , Market Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs , Integrated ... Novo Nordisk's Rare Disease portfolio. The Rare Disease portfolio includes medical treatments, customer solutions, and devices across multiple Therapy Areas… more
- Boston Scientific (Maple Grove, MN)
- …technical, or related discipline At least 2 years' experience in regulatory affairs or related discipline within the medical device industry (eg, ... continue to make an investment in Interventional treatments. This Regulatory Affairs Specialist II role will be...R&D, Quality, Clinical, Medical Affairs , Biocompatibility) Introductory knowledge of US FDA and EU… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Brand teams, other functional teams in NNI (including MAPA), including marketing, medical , R&D, regulatory affairs , finance, NNGlobal, and other ... go-to-market plan for devices for the brand portfolio (eg, single dose device , PDS290, pre-filled syringe), and maintaining strategic oversight of device -related… more
- Globus Medical (Audubon, PA)
- …Engineering degree is a plus Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within orthopedic ... their lives as quickly as possible. Position Summary: The Regulatory Affairs Specialist assists with drafting, submitting...medical devices; Experience in medical device development and registration of products… more
- Intuitive (Sunnyvale, CA)
- …[Sr. Regulatory Specialist] Experience: Minimum 5 years relevant experience working in a medical device company (can be in combination with a regulatory ... technical documentation for medical devices (can be in combination with a regulatory degree eg, Masters in Regulatory Science plus 3 years) and/or applicable… more
- Abbott (Santa Clara, CA)
- …catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out ... As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support...deadlines in a timely manner. Experience working in the Medical Device industry. Certification is a plus… 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 medical...sciences, engineering, or related field Previous experience in the medical device industry with Class II or… more
- Smith & Nephew (Pittsburgh, PA)
- … devices, including those for the US and EU markets. You act as the Regulatory Affairs (RA) lead and subject matter expert (SME) on cross-functional project ... RA Master's degree a plus 8+ years experience in Regulatory Affairs Experience with a Class II...a Class II devices Knowledge and practical application of medical device regulations (ISO, GMP, FDA, CE,… more
- Marmon Holdings, Inc. (Addison, TX)
- …CE, etc.). The Regulatory Affairs Specialist will assist in regulatory submissions, listings, and registration of medical devices to comply with ... Affairs (RA) Specialist is responsible for ensuring regulatory compliance for medical devices in accordance...degree in engineering or science discipline. 3-5 years of regulatory experience in the medical device… more
- Katalyst HealthCares and Life Sciences (Alameda, CA)
- …and guidelines related to Artificial Intelligence, Software as a Medical Device and Machine Learning (SaMD/ML). Provide regulatory guidance to product teams, ... with regulatory submissions for Artificial Intelligence, Software as a Medical Device and Machine Learning (SaMD/ML) products. Excellent attention to… more
- Boston Scientific (Marlborough, MA)
- …experience in a related discipline (eg, R&D, Quality, Clinical, Medical Affairs , Biocompatibility) in the medical device industry Introductory knowledge ... than 50 percent of all urology surgical procedures. This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance… more
- JCW Group (Austin, TX)
- …€90000 Job type: Permanent/Fixed Term Catalyst Life Sciences is on the search for a Senior Regulatory Affairs Specialist to join a team on site in Austin TX. If ... would like to be a part of aa cutting edge, Medical Device company solving cardiac and vascular challenges, then please apply! Qualifications/Responsibilities:… more
- Experis (St. Paul, MN)
- Our client, a global leader in medical device manufacturing , is seeking a Regulatory Affairs Specialist to join their team, fully remote , reporting to ... to participate in a global healthcare spin-off. Be a key contributor to regulatory affairs for medical devices and drug products. Work in a collaborative… more
- BioTalent (Westlake Village, CA)
- …Sciences, Biomedical Engineering, or a related field. 5-7 years of regulatory affairs experience in the medical device industry. Strong understanding of ... Regulatory Specialist , you will develop and implement medical device regulatory strategies to...proficiency (eg, Microsoft Word, Excel, Office, PowerPoint, and Adobe). Regulatory Affairs Certification (RAC). About Our Client:… more
- Abbott (Maple Grove, MN)
- …managing projects related to harmonized regulatory activities in the Abbott's medical device division. As an individual contributor, the function of a ... as attention to detail. Preferred Qualifications Master's Degree in Regulatory Affairs and may be used in...Material - Regulatory Review EU and US medical device compliance Project management skills -… more
