- Daiichi Sankyo, Inc. (Basking Ridge, 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 samples Project Team Participation: Provide device -specific regulatory insight/guidance during CDx Indication Team Working… more
- Merck & Co. (Rahway, NJ)
- …design.- Deep knowledge of shipping study standards and guidance, as well as medical device design controls, device risk management, design verification ... product development, analytical development, manufacturing, technical operations, packaging, quality, regulatory affairs , and clinical supplies to deliver robust… more
- JobsRUs (Cayey, PR)
- …in Biology and a minimum of one year of quality assurance/ regulatory affairs experience in a pharmaceutical/ medical device environment or an equivalent ... as required.Minimum Qualifications - Knowledge and Skills:Knowledge of current regulatory requirements in the pharmaceutical/ medical devices industry.Proficiency… more
- JobsRUs (Cayey, PR)
- …in Biology and a minimum of one year of quality assurance/ regulatory affairs experience in a pharmaceutical/ medical device environment or an equivalent ... as required.Minimum Qualifications - Knowledge and Skills:Knowledge of current regulatory requirements in the pharmaceutical/ medical devices industry.Proficiency… more
- Medtronic (Lafayette, CO)
- …industries and 5+ years of managerial experience **Nice to Have** + 10+ years of Medical Device regulatory affairs experience + An advanced degree ... + Bachelor's degree with 7+ years of regulatory affairs experience in healthcare, medical device or pharmaceutical industries and 5+ years of… more
- Olympus Corporation of the Americas (Redmond, WA)
- …high level of attention to documentation detail. + Must have an interest and curiosity for medical device Regulatory Affairs and the processes to obtain ... medical devices in various countries and geographies. Regulatory Affairs plays a critical role in... Affairs plays a critical role in the medical device industry by ensuring compliance with… more
- Medtronic (Irvine, CA)
- …field) from an accredited college or university required + Minimum of 7 years of medical device regulatory affairs experience or advanced degree with ... Irvine, CA.** **A Day in the Life** The Principal Regulatory Affairs Specialist will be vital in...and clearances. + Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485,… more
- Teleflex (Maple Grove, MN)
- …or engineering field, or equivalent work or educational experience. * 7+ years of Medical Device Regulatory Affairs experience, domestic and ... Summary** With minimal oversight, the Pr. Regulatory Affairs Specialist (PRA) for the European Union Medical... Affairs Specialist (PRA) for the European Union Medical Device Regulation (MDR) will be responsible… more
- Medtronic (Lafayette, CO)
- …regulatory affairs experience strongly preferred * 4+ years of experience in medical device regulatory affairs with roles showing increasing ... world. Bring your talents to an industry leader in medical technology and healthcare solutions - we're a market...culture. **A DAY IN THE LIFE** * Act as Regulatory Affairs representative on project transfer teams.… more
- Adecco US, Inc. (Cranbury, NJ)
- …with international regulations. **Requirements:** + Bachelor's degree + 5 years of experience in medical device regulatory affairs . + Expertise in US, ... they seeking a Senior Manager of Regulatory Affairs with a focus on Medical Devices...working in the EST time zone. **Responsibilities:** + Lead regulatory compliance efforts for medical device… more
- Philips (Nashville, TN)
- …maintained._ **You're** **the right fit if:** + You've acquired 7+ years of experience in Medical Device Regulatory Affairs , first line experience with ... **Principal Regulatory Affairs Specialist (US Hub based... medical devices globally. Experience with Software as Medical Device , and Ultrasound Imaging Devices is… more
- 3M (Maplewood, MN)
- …even further in this role include: + Master's degree in from an accredited institution + Medical Device Regulatory Affairs experience with FDA + EU MDR ... Job Description: Regulatory Affairs Associate Collaborate with Innovative...regulatory master data as required + Assure that device listings, import licenses, establishment licenses, and registrations for… more
- Astrix Technology (St. Paul, MN)
- …Degree, preferably in science, engineering, or technology. + 3-5 years of experience in Medical Device Regulatory Affairs . + Strong organizational ... Senior Regulatory Affairs Specialist Regulatory Affairs Saint Paul , MN, US Pay Rate Low: 41.88 | Pay Rate High: 47.85 + Added - 30/01/2024 Apply for Job… more
- Abbott (Santa Clara, CA)
- …business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society Certification ... best place to work for diversity, working mothers, female executives, and scientists. This ** Regulatory Affairs Specialist** will work out of our Santa Clara, CA… more
- Bausch + Lomb (Bridgewater, NJ)
- …regulatory approvals. + Knowledge of pharmaceutical, consumer or medical device industry regulatory affairs discipline throughout the product ... + Responsible for post approval lifecycle management of labeling. + Coordinate with Regulatory Affairs members and other cross-functional teams to ensure the… more
- Stryker (Fremont, CA)
- …FDA regulated industry required, preferably with medical devices. + 2-3 years of Medical Device Regulatory Affairs experience required. + Previous ... meets regulations and expectations. **What you will do** As the Staff Regulatory Affairs Specialist, you will work to maintain medical devices on the market… more
- Fresenius Medical Center (Ogden, UT)
- …Support Product Center/Project Manager to get part needed to Medical Device Compliance and Regulatory Affairs to complete Technical Dossier/Registration ... education may be considered. + Minimum 2 years in Regulatory Affairs or similar in pharmaceutical/ medical...+ Autonomy in decision making. + Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC,… more
- Teleflex (Wyomissing, PA)
- …in the science or engineering disciplines * 2-5 years in a medical device organization, preferably in regulatory affairs * Previous 510(k) experience ... Regulatory Affairs Specialist **Date:** Mar 21,...* Assist with SOP development and implementation * Maintain regulatory information systems * Support device import/export… more
- ManpowerGroup (Alameda, CA)
- …(Japanese or Chinese) **Job Description:** Experience Background (Any): Medical Device , Pharmaceutical, Regulatory Affairs , Quality Assurance, SW ... Our client is seeking a Regulatory Specialist II to join their team. **Job Title:** Regulatory Specialist II **Location:** Alameda, CA **Job Type:** 1 year… more
- Stryker (Mahwah, NJ)
- …or Advanced Degree (Masters in Regulatory Affairs ) preferred. + Medical device regulatory experience preferred. + General understanding of product ... products for regulatory classification and jurisdiction. + You will evaluate medical device regulations and develop strategies for bringing products to… more