- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience; including hands on related pharmaceutical or medical device /pharmaceutical combination product experience and actual regulatory experience ... About the Department The Clinical, Medical and Regulatory (CMR) department at...Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs .… more
- 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
- Stryker (Tempe, AZ)
- …minimum of 3 years of experience in an FDA regulated industry required; preferably in Medical Device Regulatory Affairs , Quality, or Engineering role. + ... 2+ years Regulatory Affairs experience required. + 1+ years Medical Device experience preferred. + General understanding of product development process… more
- Sanofi Group (Cambridge, MA)
- …Required:** 1-3 Years experience in the following areas: + Experience within pharmaceutical or medical device Regulatory Affairs . + Successful track ... promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as … more
- Kelly Services (Rochester, NY)
- …job might be an outstanding fit if you: * Have knowledge of medical device industry regulatory affairs throughout the product lifecycle. * Are familiar ... about this one? We're seeking a Regulatory Affairs - Specialist Global Labeling Lead Medical ... Medical Devices to work at a premier medical device company in Rochester, NY. With… more
- Abbott (Pleasanton, CA)
- …business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society Certification ... place to work for diversity, working mothers, female executives, and scientists. This ** Regulatory Affairs Specialist** **II** will work out of our Pleasanton,… 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
- 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:** Apr 19,...* Assist with SOP development and implementation * Maintain regulatory information systems * Support device import/export… 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
- ManpowerGroup (Lake Bluff, IL)
- …IT Manpower Group. Our client, Medical device manufacturing is seeking a Regulatory affairs associate to join their team. Reg Affairs , IVD or ... Device , Project Management, and previous Abbott would be ideal **Job Title: Regulatory Affairs Associate** **Pay Range: $33/hr** **Location:** 100 Abbott Park… more
- GE HealthCare (WI)
- …at least 6 years of relevant work experience) with 3 years of relevant experience in medical device regulatory affairs + Ability to drive problem solving ... Characteristics:** + Advanced degree in scientific, technology or legal disciplines + Regulatory Affairs Certification (RAPS) + Team-oriented and responsive to… more
- Medtronic (Santa Rosa, CA)
- …profile. + Bachelor's degree. + Minimum of 7 years of direct Regulatory Affairs experience within the medical device industry + Or advanced degree ... with a minimum of 5 years of Regulatory Affairs experience within the medical device industry Desired/Preferred Qualifications + Direct Regulatory … more
- Stryker (Mahwah, NJ)
- …or Advanced Degree (Masters in Regulatory Affairs ) preferred. + Medical device regulatory experience preferred. + General understanding of product ... 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
- Cordis (Irvine, CA)
- …equivalent professional experience. * 2+ years of experience in regulatory affairs in medical device /pharmaceutical industry, GLP, ISO 13485 environment ... **Overview** MedAlliance is a leading and innovative combination medical device company dedicated to improving patient outcomes and enhancing healthcare… more
- Actalent (Round Lake, IL)
- …meetings with health agency. Skills: Regulatory Affairs , FDA, Regulatory Submissions, IND, NDA, 510K, Pharmaceutical, Medical Device , Quality ... Assurance Top Skills Details: Regulatory Affairs ,FDA, Regulatory Submissions Additional Skills & Qualifications: BS Degree with 2-4 Years of related … more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …your best self. Become a **maker of possible** with us. **SUMMARY** The Regulatory Affairs Specialist I are responsible for implementation of regulatory ... duties **QUALIFICATIONS:** + Knowledge of the US and European medical device regulations preferred + Must have... product registration, compliance or quality systems; or + Regulatory Affairs Certification (RAC) desired For certain… more
- J&J Family of Companies (West Chester, PA)
- …NA-US-Pennsylvania-West Chester **Organization** Medical Device Business Services, Inc (6029) **Job Function** Regulatory Affairs **Req ID:** 2406175724W ... Regulatory Affairs Specialist II (DePuy Synthes) - Medical Device Business Services, Inc. - 2406175724W **Description** DePuy Synthes, Inc. is currently… more
- J&J Family of Companies (Raynham, MA)
- …NA-US-Massachusetts-Raynham **Organization** Medical Device Business Services, Inc (6029) **Job Function** Regulatory Affairs **Req ID:** 2406183699W ... Regulatory Affairs Specialist I (Depuy Synthes/Spine) - Medical Device Business Services, Inc. (1 of 2) - 2406183699W **Description** DePuy Synthes, part… more
- Sanofi Group (Cambridge, MA)
- …+ CyberSecurity Expertise **Stakeholders outside of Digital:** + Global Regulatory affairs + Global Medical Device Quality + Pharmacovigilace + ... Our team has released an FDA certified class II medical device titration application. We are gearing...and customer requirements. The position contributes directly to meeting regulatory submission and launch timelines of the software as… more
- Actalent (Minneapolis, MN)
- …task as assigned. * Works well in a team to accomplish team goals. Top Skills: Regulatory affairs , Medical device , Regulatory submission, FDA, ... a quality/compliance/ regulatory organization + Experience with or knowledge of medical terminology and how medical /pharmaceutical products are typically used… more
