- 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 ... comparable required. + Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device...coverage effective on start date + 24/7 Employee Assistance Program + Free live and on-demand Wellbeing Programs +… more
- 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 ...coverage effective on start date + 24/7 Employee Assistance Program + Free live and on-demand Wellbeing Programs +… more
- Chiesi (Boston, MA)
- …Promotional Material/External Communications Responsibilities: + Work in the Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, ... product risks are appropriately communicated. + Provide training to Regulatory Affairs and other departments as appropriate....(as well as any other discretionary payment or compensation program ) at any time, including for reasons related to… more
- Cardinal Health (Boston, MA)
- …Device Regulatory Affairs /Quality experience preferred + Certification in regulatory affairs program preferred + Effective project management skills ... **_What Regulatory Affairs contributes to Cardinal Health_**...on STEDs. + Support development, maintenance and implementation of regulatory procedures. + Under direction of manager ,… 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 ... or auditor inquiries as directed. + Interface with International Regulatory Affairs Team and drive preparation of...coverage effective on start date + 24/7 Employee Assistance Program + Free live and on-demand Wellbeing Programs +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …(https://www.olympusamerica.com/careers) . **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified, fellowship trained ... proficient in endoscopy with deep clinical practice knowledge, medical affairs industry experience, and/or health leadership competencies and management… more
- Parexel (Boston, MA)
- If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from ... dedicated client partnership and play a pivotal role in their regulatory affairs department. Key Responsibilities: Collaborative Coordination: Work closely… more
- Dana-Farber Cancer Institute (Boston, MA)
- …in collaboration with key stakeholders + Meet regularly with program manager (s) to review and collaborate regarding regulatory workload prioritization. Work ... to the CTIP Associate Director for Reg unit, the Regulatory Operations Manager (ROM) will oversee the...active and close out phases + Proficient knowledge of regulatory affairs , research ethics and the responsible… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be responsible ... negotiations with Health Authorities. + Ensures labeling content conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Takeda Pharmaceuticals (Lexington, MA)
- …candidates pursuing an advanced degree such as a Master's in Life Sciences, PharmD, Regulatory Affairs (Degree or Certification), JD, or MBA are encouraged to ... basic understanding of scientific principles + Ability to understand broad concepts within Regulatory Affairs + Ability to proactively identify regulatory … more
- Wolters Kluwer (Waltham, MA)
- The **Principal SaMD Technical Program Manager ** plays a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. ... The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs , clinical, and quality assurance teams, facilitating strategic… more
- Medtronic (Newton, MA)
- …work together to engineer the extraordinary. Join Medtronic as a **Software Reliability Engineering Program Manager - Quality Core Team Member** and be at the ... workflow and product knowledge. + Collaborate with cross-functional teams, including R&D, regulatory affairs , and clinical teams, to ensure alignment on quality… more
- Eversource Energy (Westwood, MA)
- …J\-1, O\-1, etc\.\)\. **Our Team** Eversource is looking for a **Senior Program Manager , Strategic Project Development, Transmission** located in **Westwood, ... and budgets in the conceptual phase prior to execution + Interacts regularly with Regulatory Affairs , Environmental Affairs , and Energy Efficiency to develop… more
- Takeda Pharmaceuticals (Boston, MA)
- …work allowed from anywhere in the US **REQUIREMENTS:** Bachelor's degree in Pharmacy, Regulatory Affairs , Clinical or related field plus 5 years of related ... the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION:** Clinical Program Quality Manager **POSITION DESCRIPTION:** Takeda Development Center… more
- Dana-Farber Cancer Institute (Boston, MA)
- …in the clinical research field is preferred. + Experience in knowledge of regulatory affairs , research ethics, and Responsible Conduct of Research (RCR) is ... of translational research principles and biobanking processes. + Basic knowledge of regulatory affairs , research ethics, and responsible conduct of research +… more
- Wolters Kluwer (Waltham, MA)
- **Job Title: Project Manager -** **Operations** **CoE** **About Wolters Kluwer** Wolters Kluwer is a global leader in professional information, software solutions, ... nurses, accountants, lawyers, and tax, finance, audit, risk, compliance, and regulatory sectors. We help professionals deliver deep impact when it matters… more
- Philips (Cambridge, MA)
- **Medical Safety Manager , Complaints Handling** The Medical Safety Manager , Complaints Handling, performs clinical assessments on complaints related to harm to ... assist in regulatory reportability determination and serves as the primary clinical...with a master's equivalent in areas such as Medical/Clinical Affairs or Medical Safety/Medical Affairs Risk Management… more
- Hologic (Marlborough, MA)
- …the highest quality. Collaborate with top talent across Clinical Development, R&D, Regulatory Affairs , Program Management, Legal, Marketing, and Operations ... United States Marlborough, MA, United States Join the Breast and Skeletal Health Clinical Affairs team as a **Clinical Project Manager ,** leading major US and… more
- Point32Health (Canton, MA)
- …engagement with senior leaders at contracted provider organizations. + **Risk Adjustment Program Management and Vendor Evaluation** : The Manager will be ... and reporting to identify improvement opportunities and recommend changes to improve program results and effectiveness. The Manager will collaborate with key… more
- ConvaTec (Lexington, MA)
- …with cross functional team members including, but not limited to, regulatory , R&D, project/ program management, data management, and medical monitors. ... compliance with all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Convatec's policies and SOPs. **Key Responsibilities:** +… more