- Olympus Corporation of the Americas (Westborough, MA)
- …supports the Global Senior Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not limited to analysis of requirements ... medical devices. This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class ...and relevant consumer protection laws). + Oversee and support regulatory submissions and compliance filings where applicable… 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 ... in vendor and technology selection. + Oversee and support regulatory submissions and compliance filings where applicable...comparable required. + Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device… 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
- Teleflex (Minneapolis, MN)
- Clinical Affairs Manager , Interventional Access (REMOTE) **Date:** Nov 9, 2025 **Location:** Minneapolis, MN, US **Company:** Teleflex **Expected Travel** : Up ... **TRAVEL REQUIRED: 50% (Domestic and International; overnight required)** The Clinical Affairs Manager will provide clinical expertise, insight, and support… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... in the biotech or pharmaceutical industry, with exposure to regulatory activities/ submissions and 3 years working on... and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience… more
- BeOne Medicines (San Mateo, CA)
- …expectations. This role provides compliance oversight and guidance across Regulatory Operations, Regulatory Affairs , Quality, Safety/Pharmacovigilance, ... **General Description** **:** The Manager , Regulatory Compliance Programs reports to...system. + Monitor data quality, integrity, and completeness of regulatory records, including submissions , HAQs, commitments, and… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Scientific Affairs group, an integral delivery unit within the Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable for driving ... management deliverables supporting the Olympus portfolio. The Sr. Clinical Data Manager designs, develops, and maintains key data management deliverables used to… more
- BeOne Medicines (San Mateo, CA)
- …in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems ... the region to senior management and Global Clinical Study Manager as required + Represents the regional study team...other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs + Accountable for submissions… more
- BeOne Medicines (Emeryville, CA)
- …centralized teams for Statistical Programming + Experience in FDA/EMEA/CFDA trial and regulatory submissions + Experience with the drug development process ... collaborate with cross-functional teams, including biostatistics, epidemiology, and medical affairs to design, implement, and deliver high-quality analytic datasets,… more
- Lundbeck (Deerfield, IL)
- …ordering systems, tracking, and reporting. Additionally, in partnership with Regulatory Affairs , Promotional Review Committees (PRC/MLR), and Marketing, ... of promotional material inventory, fulfillment, and compliance, FDA 2253 submissions and field operations day to day support. The...+ 2 years of experience in Biotech or Pharmaceutical regulatory operations, regulatory affairs , marketing… more
- Alameda Health System (Oakland, CA)
- …Imaging in interdepartmental initiatives involving IT, Quality, Education, Compliance, and Regulatory Affairs . **DUTIES & ESSENTIAL JOB FUNCTIONS:** NOTE: The ... point of contact for ACR surveys, follow-up activities, and imaging quality sample submissions . Ensure continuous regulatory readiness for TJC, CMS, and CDPH-RHB… more
- Dentsply Sirona (Milford, DE)
- …for medical devices and other regulated products globally. + Leads and manages regulatory submissions , including 510(k) submissions , and technical files for ... + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited...in the medical device industry. + Experience with leading regulatory submissions and managing regulatory … more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- … Regulatory Affairs , Advertising and Promotion Director. The Associate Manager Regulatory Affairs , Advertising and Promotion will oversee therapeutic ... Manager , of Advertising and Promotion to join our Regulatory Affairs team!! **In this role, a...to advertising and promotion matters, including request for advisory submissions . + Responsible for compliance with promotional material … more
- J&J Family of Companies (Santa Clara, CA)
- …of sonic pressure waves for the treatment of calcified plaque. **Position Overview** The Regulatory Affairs Manager works closely and partners with internal ... meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Regulatory Affairs Manager combines knowledge of scientific, regulatory… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function ... manager will be responsible for FDA meetings and submissions for their assigned projects. This role is responsible...their assigned projects. This role is responsible for linking regulatory affairs information to internal and external… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC**...the regulatory SME, provide support for compiling regulatory submissions , and ensuring data is effectively… more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... and filing 510(k), IDE, PMA submissions , FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely … more
- GE HealthCare (Chicago, IL)
- …working closely with healthcare regulatory bodies globally. + Prepares global regulatory submissions by working across the regulatory organization and ... strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions /registrations...biologics. + A minimum of 5 years' experience in Regulatory Affairs . + A minimum of 5… more
- Abbott (Alameda, CA)
- …working mothers, female executives, and scientists. + The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Lingo team in Alameda ... CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is...related discipline + Previous experience with Class III IDE submissions and/or PMA submissions or EU Technical… more
- Abbott (Alameda, CA)
- …years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. + Experience with ... their glucose levels with our new sensing technology. **The Opportunity** The **RA Manager ** will work on-site out of our Alameda, CA location in the Diabetes… more
