- Fresenius Medical Center (Waltham, MA)
- …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
- Beth Israel Lahey Health (Boston, MA)
- …+ Bachelor's degree in Life Science or related field required; Master's degree in Regulatory Affairs preferred. + Minimum of 3-5 years related work experience ... 32 **Work Shift:** Rotating (United States of America) The Sr . Regulatory Specialist supports regulatory ...Center (BIDMC). The position is flexible in terms of remote versus onsite work. A part-time opportunity is available.… more
- Commonwealth Care Alliance (Boston, MA)
- …Healthcare Compliance (CHC) preferred. + 5 or more years direct work experience in regulatory affairs and/or compliance in Medicare or Medicaid required + 5 or ... to regulators + Submit materials to regulators + Coordinate attestations from Senior Leadership for submission **Compliance Regulatory Guidance Distribution** +… more
- Fresenius Medical Center (Waltham, MA)
- **POSITION FEATURES:** This is a remote position with 25% travel **PURPOSE AND SCOPE:** Manages a field team of regulatory compliance employees and provides ... existing trends and new initiatives related to state and federal regulatory activities. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + Maintains current/high level… more
- Merck (Boston, MA)
- **Job Description** The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs ... model to maintain best-in-industry regulatory compliance. The Vice President Regulatory Affairs , General Medicine is accountable for: + Directing and… more
- Danaher Corporation (Boston, MA)
- …reimagine healthcare, one diagnosis at a time. You will be a part of the CCIA Clinical Affairs team and report to the Senior Manager Clinical Affairs who is ... tools that address the world's biggest health challenges. The Clinical Affairs Manager for Beckman Coulter Diagnostics is responsible for directly managing… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... values by staying **True to Life.** **Job Description** The Sr . L&D Specialist, Global QMS Training will serve as...L&D Specialist, Global QMS Training will serve as a senior individual contributor within Quality. This individual will support… more
- Edwards Lifesciences (Boston, MA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… 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) ... date on the latest global regulations. + Collaborate closely with the Quality, Regulatory , R&D, Business Development, Medical & Scientific Affairs , IT, and… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The ** Senior Clinical Director ( Sr . Principal Scientist)**...pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior … more
- Sanofi Group (Cambridge, MA)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global), in early and ... ** Regulatory Strategist** + Location: Cambridge, MA + Remote Work: Hybrid + Job Type: Full Time **About...regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed. + May lead Health Authority… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... staying **True to Life.** **Job Description** Leads and directs regulatory compliance communications to ensure compliance of the Global...areas of compliance risk and present these risks to senior leadership at Olympus in a clear and concise… more
- Commonwealth Care Alliance (Boston, MA)
- …including budget development, staff resource allocation and shaping the overall Regulatory Affairs Compliance infrastructure. + Promote compliance in CCA's ... day compliance activities across the organization. + Serve as Regulatory Affairs and Compliance liaison with key...in meetings and to communicate with team members and senior leadership + Requires excellent interpersonal skills in order… more
- Takeda Pharmaceuticals (Boston, MA)
- … management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive Director and ... life-changing therapies to patients worldwide. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will...Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will… 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) ... our core values by staying **True to Life.** **Job Description** The Senior Supplier Quality Engineer, Software is responsible for the product-related supplier… more
- Bristol Myers Squibb (Boston, MA)
- …child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. **\#LI- Remote , #** **BMSNEURO** _If you come across a role ... . Reporting into the Medical Value Liaison Field Director, the Senior Medical Value Liaison (MVL)/Executive MVL is a field-based role focused… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... and our core values by staying **True to Life.** **Job Description** The Senior Quality Engineer is responsible for CAPA ownership, execution, and support for Market… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in Lexington, MA with the following requirements: Bachelor's degree in Clinical, Regulatory Affairs , Pharmacy, or related field or foreign academic equivalent ... vulnerable points in the PV domain. Up to 10% travel required. Up to 100% remote work allowed from anywhere in the US Full time. $195,458 - $223,200 per year.… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... our core values by staying **True to Life.** **Job Description** The Senior Supplier Quality Engineer is responsible for the product-related supplier quality within… 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