- Olympus Corporation of the Americas (Westborough, MA)
- …preferred, BS or comparable required + Minimum of 5-7 years experience in Regulatory Affairs in Medical Device Industry with focus on Software driven ... / Machine Learning-enabled medical devices + Expert in Regulatory Affairs for Software as a Medical Device and Class I/II/III medical devices.… more
- Cordis (Irvine, CA)
- …**Experience:** 5 years of experience in technical writing, preferably in regulatory affairs or the medical device sector. + **Knowledge:** Familiarity ... are currently seeking a **Technical Writer** to join our Regulatory Affairs department, focusing on the development...with medical device regulations (FDA, ISO 13485, ISO 14971, and ISO… more
- Medtronic (Santa Rosa, CA)
- …+ Bachelor's degree required. + Minimum of 2 years of experience in regulatory affairs in the medical device industry. + Or advanced degree with a ... minimum of 0 years of experience in regulatory affairs in the medical device industry. **Nice to Have (Preferred Qualifications):** + Effective and… more
- Cordis (Irvine, CA)
- …will possess strong clinical experience and a proven track record in regulatory affairs within the medical device industry. **Responsibilities** + Lead ... advanced degree preferred. + 8-10 years of experience in regulatory affairs within the medical device industry, with a strong focus on PMA submissions. +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and future approvals to management. **Job Qualifications** **Required:** + Regulatory affairs experience in the Medical Device industry is mandatory ... it is likely not legitimate._ **Job Description** Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices in the… more
- Spectrum Plastics Master (Tucson, AZ)
- …in a related field, and a minimum of 5 years directly related to Regulatory Affairs experience in the medical device industry + Current knowledge of FDA ... commonly used concepts, practices, procedures and business principles within regulatory submissions in a medical device...business principles within regulatory submissions in a medical device industry + Knowledge of Post… more
- Globus Medical, Inc. (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 drafts, submits and gains...medical devices; + Experience in medical device development and registration of products… more
- ZOLL Medical Corporation (Chelmsford, MA)
- … or Regulatory Affairs Certification preferred + Experience with medical device regulatory submissions (510(k) or PMA preferred + Experience ... compliance and timely product clearances and/or approvals. + Represent regulatory affairs on project/product teams, risk management,...with medical device submissions preferred + C ommissioned… more
- Olympus Corporation of the Americas (Center Valley, PA)
- … or Science (or similar) is required. Master's degree preferred. + Experience in medical device Regulatory Affairs , Quality Assurance, or Research ... is likely not legitimate._ **Job Description** The Senior Specialist, Regulatory Affairs Operations - Regulatory ...activities. + Has a broad understanding of the global medical device regulatory landscape, … more
- Teleflex (Morrisville, NC)
- …or engineering field, or equivalent work or educational experience. * 7+ years of Medical Device Regulatory Affairs experience, domestic and ... Principal Regulatory Affairs Specialist **Date:** Nov 1,...:11132 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to… more
- Stryker (Mahwah, NJ)
- …Engineering, Science, or related degree required + Minimum of 2 years of experience in medical device regulatory affairs required + Time management ... regulatory agencies and notified bodies. The Senior Regulatory Affairs Specialist is the Regulatory...Affairs ) preferred + Knowledge of FDA and international medical device regulations and standards (eg EU… more
- Teleflex (Chelmsford, MA)
- …in a science or engineering field, or equivalent work experience. * 5+ years of Medical Device Regulatory Affairs experience, domestic and international. ... Sr. Regulatory Affairs Specialist **Date:** Nov 21,...:11196 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to… more
- Medtronic (Boston, MA)
- …years of experience in regulatory affairs **Nice to Have** + 4+ years of medical device regulatory affairs experience + Local to CO and willing ... compassionate world. **A Day in the Life** We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and Monitoring… more
- Caldera Medical (Westlake Village, CA)
- …with RAPS, ASQ, CQE preferred. * 3-5 years experience in International Regulatory Affairs preferably in the Medical Device industry. * Experience with ... regulatory specialist, you will develop and implement medical device regulatory strategies to...Excel, Office, PowerPoint, and Adobe). * Regulatory Affairs Certification (RAC). Who is Caldera Medical ?… more
- Stratasys (Eden Prairie, MN)
- …this role** + 10+ years of experience in quality assurance and regulatory affairs , with a significant portion in medical device , or advanced ... VP, Quality & Regulatory Affairs Location: Eden Prairie, MN,...as experience interacting with key customers, specifically in the medical device sector. **What you will be… 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
- Eurofins (Boston, MA)
- …+ Build and lead a team of skilled consultants with expertise in medical device testing, regulatory affairs , and quality management. + Foster a culture ... to support our clients in the medical device industry across their product innovation, regulatory ...entire product lifecycle, from pre-clinical and clinical support to regulatory affairs and market access. Key Responsibilities:… more
- AbbVie (Irvine, CA)
- …objectives, both strategic and applicable regulatory requirements. Director, Safety, Regulatory and Medical Affairs Quality Standards is responsible ... for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical ...quality oversight of GxP activities, covering the AbbVie drug, device and cosmetic portfolio. The role oversees generation and… more
- Abbott (Scarborough, ME)
- …of education and experience. + 2+ years' experience in Quality Assurance Regulatory Affairs role in the Medical Device Industry + Knowledge of ... Communicate laws/regulations, standards, and guidance documents pertaining to software in the medical device industry, with awareness of patient risk, and legal… more
- Abbott (Sylmar, CA)
- …location in Sylmar, CA currently has an on-site opportunity for a **Senior Regulatory Affairs Specialist** with our Cardiac Rhythm Management division. This ... ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more