- Olympus Corporation of the Americas (Westborough, MA)
- …and connected technologies aligned with the Business Unit priority. Interface with International Regulatory Affairs Team to ensure global planning ... traditional 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)
- …and responses to regulatory or auditor inquiries as directed. Interface with International Regulatory Affairs Team and drive preparation of dossiers for ... Life at Olympus: https://www.olympusamerica.com/careers . Job Description The Sr. Regulatory Affairs (RA) Specialist II Digital Health...registration on for other international markets such as Japan, Middle East and Africa,… more
- Carrier (Beverly, MA)
- …manage submissions and regulatory changes, and support product launches across international markets. The Regulatory Affairs & Compliance Lead expertise ... committed to innovation, sustainability, and global impact. About this role As the Regulatory Affairs & Compliance Lead at Sensitech , you will be the … more
- Schwan's Company (Minneapolis, MN)
- …- Bachelor's degree in Microbiology, Chemistry, Food Science, Food Safety and Technology, Regulatory Affairs , International Trade, or closely related field. ... and global food safety risks. Serve as liaison with Scientific & Regulatory Affairs to anticipate impacts and align company strategies with evolving … more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs , Tactical Implementation, on the Regulatory Affairs ... possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs , Tactical Implementation, you'll have a critical role in… more
- Eisai, Inc (Nutley, NJ)
- …broad pharmaceutical industry experience, including 8 years of direct Regulatory Affairs experience with new/innovative drug registration strategy/submissions. ... Transparency Language:The annual base salary range for the Director, Global Regulatory Affairs , Growth Markets is from :$200,800-$263,600Under current… more
- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in regulatory submissions across ... multiple regions (US, EU, and/or other international markets)Strong knowledge of global regulatory requirements and submission formats (eCTD)Proven experience… more
- J&J Family of Companies (Raynham, MA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs ... We are searching for the best talent for a Regulatory Affairs Specialist II to support our...licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, including, but not limited to… more
- West Pharmaceutical Services (Exton, PA)
- Sr. Specialist Regulatory Affairs , MD Requisition ID 71773 Date Nov 21, 2025 Location Exton, Pennsylvania, US Department Regulatory Affairs Description ... and planet through our sustainability efforts. Job Summary The Regulatory Affairs Sr. Specialist is responsible for...the company's safety and quality policy at all times International regulatory competency Knowledge of 21 CFR… more
- Abbott (Minneapolis, MN)
- …get on with their lives. The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. ... including those set by the FDA or other worldwide regulatory agencies to various international affiliates. Maintains...etc.), math, engineering, or medical fields. Master's degree in Regulatory Affairs . Regulatory experience with… more
- Dentsply Sirona (Waltham, MA)
- …enhancing business relationships. Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, ... degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. ...regulatory projects. In-depth knowledge of FDA 510(k) and international regulations (eg, EN ISO 13485, EU MDR). Experience… more
- Parexel (St. Paul, MN)
- …go-to expert for global labeling, working side-by-side with client teams across Regulatory Affairs , Technical Operations, Safety, and Commercial. You'll help ... navigate the complex regulatory landscape, ensure compliance across international markets,...ideal for a candidate with a strong background in regulatory affairs , labelling strategy, and cross-functional leadership.… more
- Teleflex (Morrisville, NC)
- …science or engineering field, or equivalent work experience. 5+ years of Medical Device Regulatory Affairs experience, domestic and international . 3 years of ... Senior Regulatory Affairs Specialist Date: Dec 2,...III medical devices. Proven history of successful domestic and/or international submissions. Specialized Skills / Other Requirements Strong analytical… more
- Medtronic (Minneapolis, MN)
- …and manufacturing site registrations A Day In The Life Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff ... connected, compassionate world. A Day in the Life SENIOR REGULATORY AFFAIRS SPECIALIST In collaboration with leading... issues and questions. Interact directly with FDA and international regulatory agencies on most projects/products at… more
- Olympus Corporation of the Americas (Westborough, MA)
- …of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will ... or comparable required. Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device...Experience with 510(k), De Novo submissions, CE marking, and international regulatory pathways for Software as a… more
- Grifols Shared Services North America, Inc (Durham, NC)
- …and services in more than 110 countries and regions. Summary: The Regulatory Affairs Surveillance Specialist will determine and execute actions necessary ... of regulatory requirements and changes in the regulatory landscape. Communicate with US and international ...and activities, as required. Must be able to perform Regulatory Affairs Specialist role. May review submissions/… more
- Insmed Incorporated (NJ)
- …in IT with focus on healthcare/pharmaceutical industryExperience with medical affairs processes and regulatory environmentsStrong technical knowledge of ... science, we're in. Are you?About the Role:The IT Business Partner for Medical Affairs and Innovation serves as a strategic liaison between Information Technology and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- Job Summary The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- Sanofi Group (Framingham, MA)
- Job Title: Global Regulatory Affairs CMC lead Location: Framingham, MA, Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is ... approvals through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role… more
- Abbott (Minneapolis, MN)
- …on with their lives. The Opportunity Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site in Plymouth, MN. ... guidance and expertise on complex worldwide strategies with the help of international regulatory affiliates. Compile, prepare, review and submit medical device… more
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