- 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 ... medical devices. This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class ...Olympus' digital transformation journey. This position supports the Global Senior Manager to plan and direct the OSTA Core… more
- Eliassen Group (Marlborough, MA)
- ** Senior / Principal Regulatory Affairs Specialist** **Marlborough, MA** **Type:** Permanent **Category:** Q&R **Industry:** Life Sciences **Reference ID:** ... developing laser and pulsed field ablation systems for atrial fibrillation. The regulatory function integrates with engineering and clinical teams and contributes to… more
- Parexel (Boston, MA)
- …markets? Parexel is seeking an experienced and highly motivated **Global Regulatory Labeling Lead** to provide strategic leadership and operational oversight for ... This role is integral to the development, governance, and maintenance of regulatory labeling content that supports the safe and effective use of products… more
- GRAIL (Boston, MA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... regulatory approval. + Monitor and report on international regulatory developments and LDT requirements that...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- Dentsply Sirona (Waltham, MA)
- …channels, enhancing business relationships. + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to ... degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. +... projects. + In-depth knowledge of FDA 510(k) and international regulations (eg, EN ISO 13485, EU MDR). +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the… more
- Bristol Myers Squibb (Cambridge, MA)
- …more: careers.bms.com/working-with-us . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for ... Solid scientific background, PhD., MD, PharmD, MS + Significant experience in regulatory affairs and diagnostic-related development eg, >8-10 years. + Scientific… more
- Takeda Pharmaceuticals (Boston, MA)
- …across congresses, professional societies, and key opinion leaders (KOLs). As a senior leader within the GMAO Medical Capabilities team, this individual will drive ... engagement strategy, and Independent Medical Education strategy. + Serve as the senior medical point of contact for external scientific engagement strategy across… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... The Senior Director, Medical Communications, CNS directs and provides...accuracy, consistency, and alignment with the overall CNS Medical Affairs strategy. The role is a key leadership position… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Senior Director, Medical Communications, Nephrology & Immunology directs and provides strategic leadership for the global scientific ... accuracy, consistency, and alignment with the overall Nephrology & Immunology Medical Affairs strategy. The role is a key leadership position within the Nephrology… more
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