- ZOLL Medical Corporation (Chelmsford, MA)
- …a purpose.Join our team. It's a great time to be a part of ZOLL!Job SummaryThe Senior Regulatory Affairs Program Lead is responsible for managing the ... with cross-functional stakeholders to ensure regulatory compliance is met. The Senior Regulatory Affairs Program Lead will oversee the technical… more
- Astellas Pharma (Westborough, MA)
- …eligible positions + Long Term Incentive Plan for eligible positions + Referral bonus program \#LI-TR1 Category Regulatory Affairs CMC Astellas is committed ... ** Regulatory Manager, Regulatory Affairs ...with functional peer groups internally and externally, occasionally with senior management. + Advises local teams on regulatory… more
- Takeda Pharmaceuticals (Lexington, MA)
- …life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will develop and lead the execution ... As part of the Regulatory CMC team, you will report to a Senior Director and work with stakeholders across the business. **How you will contribute:** + As… more
- Fresenius Medical Center (Waltham, MA)
- …can be fully remote. **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product ... compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. POSITION ACCOUNTABILITIES: + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... **Job Description** About the role: Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … more
- AbbVie (Waltham, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory ... regarding work processes or operational plans and schedules to achieve the program objectives established by senior management. Advances the organization's goals… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …Bachelor's Degree preferred + 3-5+ yrs. related experience preferred + Certification in Regulatory Affairs program Preferred Knowledge, Skills and Abilities ... surrounding departments such as Quality Assurance, Compliance, Technical Support, Service, and Regulatory Affairs . Involved in several aspects of Post Market… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... timely completion of applicable Customer Quality commitments to US FDA, and other Regulatory Authorities as applicable. + Leads cross site / functional teams on… more
- Novo Nordisk (Lexington, MA)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director can be accountable for the Clinical pharmacology strategy for phase 1-4 in ... Clinical Development program (s), Dosage and administration strategy, including dose setting and dosing regimen for project(s), Scientific and pharmacology aspects of… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... working knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, ISO 11135,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …perspective. Matrixed relationships within Olympus will include colleagues from Quality Assurance, Regulatory Affairs , IP R&D teams, and the Infection Prevention ... Collaborate with the Chief Medical Safety Officer, Chief Medical Officer, and other senior leaders within Medical and Scientific Affairs to share best practices… more
- Novo Nordisk (Lexington, MA)
- … Medical Director Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be ... + Work with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... regulators ensuring communicationsadhere the Global Quality System and applicable regulatory requirements. + Responsible for reviewing complaint handling requests… more
- Olympus Corporation of the Americas (Westborough, MA)
- …purchasers, payers and policy makers + Coordinate with Medical & Clinical Affairs , Regulatory to ensure appropriate support and guidance when addressing ... outcomes research in the pharmaceutical/biotechnology or medical device industry + Senior level competence in US reimbursement coding, coverage and innovative… more