- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in regulatory labeling operations and process optimization. Experience with project coordination or operational support in a corporate setting. Familiarity ... around rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Labeling Operations Intern for Summer 2026. This full-time… 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 ... product development for assigned programs. This role will provide regulatory input to global cross-functional project teams...care you bring to your work each day, with support for how you work, how you grow, and… more
- J&J Family of Companies (Raynham, MA)
- …packaging, advertising and promotional materials after evaluating conformance to regulations. Provide Regulatory Affairs support during internal and external ... We are searching for the best talent for a Regulatory Affairs Specialist II to support...for Regulatory Affairs processes. Represents Regulatory Affairs on cross-functional project … more
- Olympus Corporation of the Americas (Westborough, MA)
- …healthcare beyond traditional medical devices. This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class regulatory strategies ... position supports the Global Senior Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not limited to analysis of… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …us. Functional/Organizational Summary This position will be working in BD-Connected Care on Regulatory Affairs projects that support the Pharmacy Automation ... Master's degree in life sciences field (preferred over Bachelor's) RAC certification ( Regulatory Affairs Certification) PMP certification ( Project Management… 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...global regulations Provide leadership to product development teams for regulatory issues and questions Provide support to… more
- Olympus Corporation of the Americas (Westborough, MA)
- …more about Life at Olympus: https://www.olympusamerica.com/careers . Job Description The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports ... teams for sustaining products to provide input on global regulatory requirements. Support regulatory submissions,... or auditor inquiries as directed. Interface with International Regulatory Affairs Team and drive preparation of… more
- Medtronic (Minneapolis, MN)
- …with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies ... connected, compassionate world. A Day in the Life SENIOR REGULATORY AFFAIRS SPECIALIST In collaboration with leading...with engineering partners, geography regulatory partners, and regulatory agencies as needed. Support regulatory… 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, ... FDA 510(k) submissions and EU technical files submissions. Provides regulatory guidance and support to cross-functional teams...degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. … more
- Teleflex (Morrisville, NC)
- Senior Regulatory Affairs Specialist Date: Dec 2, 2025 Location: Morrisville, NC, US Company: Teleflex Expected Travel : Up to 10% Requisition ID :12987 About ... solutions that make a difference in patients' lives. Position Summary The Sr. Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies,… 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. ... Abbott customers. May interface directly with FDA and other regulatory agencies if so directed. Support all...etc.), math, engineering, or medical fields. Master's degree in Regulatory Affairs . Regulatory experience with… 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 ... due diligence in vendor and technology selection. Oversee and support regulatory submissions and compliance filings where...or comparable required. Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device… more
- Insmed Incorporated (NJ)
- …processes and regulatory environmentsStrong technical knowledge of medical affairs applications and IT infrastructureProficiency in project management ... serves as a strategic liaison between Information Technology and Medical Affairs departments, driving technology initiatives that support medical excellence,… more
- Teleflex (Reading, PA)
- …system compliance requirements. The Senior RA Associate will partner with Product Management Regulatory Affairs personnel to support 510(k)s, Canada License ... Sr. Regulatory Affairs Associate Date: Nov 24,...MDR technical files and documentation to ensure continued compliance. Support regulatory compliance activities, including Health Canada… 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 ... departmental projects and activities, as required. Must be able to perform Regulatory Affairs Specialist role. May review submissions/ applications compiled by… 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
- Parexel (Little Rock, AR)
- … leads in developing contingency plans for CMC-related scenarios Represent CMC Regulatory Affairs in cross-functional project meetings and provide ... Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs … 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
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. Position Summary : The Lead Regulatory Affairs Specialist oversees the preparation and submission of regulatory ... and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting Reviews Document Change Orders… more
