- 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
- Philips (Cambridge, MA)
- ** Senior Regulatory Affairs Manager (US Hub based location)** The Senior Regulatory Affairs Manager will develop and communicate a vision for the ... strategy in the area of regulatory submissions. You will manage a Regulatory Affairs team supporting various new and sustaining programs for Philips… 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
- Merck (Boston, MA)
- **Job Description** **Global Senior Director of Medical Affairs for Thoracic Malignancies** + The Global Senior Director of Medical Affairs (GDMA) for ... edge of therapeutic and patient care advances. + The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset… more
- Commonwealth Care Alliance (Boston, MA)
- **Why This Role is Important to Us:** Under direction of the Sr . Director of Regulatory & External Audits, the primary focus areas of this position includes ... and resulting Corrective Action Plan (CAP). This includes audits from external regulatory agencies including but limited to Centers for Medicare & Medicaid Services… 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
- Merck (Boston, MA)
- **Job Description** The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs ... in industry regulatory compliance. The Vice President Regulatory Affairs , General Medicine is accountable for:...health authorities. Leads, develops, and coaches a team of senior level employees to effectively manage programs and enable… 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
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- …and community events either separately or in conjunction with the Public Affairs Office. Displays knowledge of Department priorities and mission statements to ... veteran organization, and community organization meetings with facility and regional senior leader staff members. Reviews and reports on policies in preparation… more
- Veterans Affairs, Veterans Health Administration (Brockton, MA)
- …The incumbent holds primary responsibility for preparing the unit for accreditation, regulatory , and safety reviews. The incumbent looks for opportunities within the ... influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Participation in the Coronavirus Disease 2019… more
- J&J Family of Companies (Boston, MA)
- …team members for completeness, accuracy, and structure + Work closely with Regulatory Affairs , Analytical Development, API Process Development, Drug Product ... Senior Scientific Integrator, Regulatory CMC Dossier...CMC Dossier - Biotherapeutics based in Spring House, PA. Remote work options may be considered on a case-by-case… 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) ... by staying **True to Life.** **Job Description** The Manager, Senior Global MDR Submission is responsible for managing Market...for managing Market Quality- COE MDR team for the regulatory assessment and submission of Medical Device Reports to… 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
- Merck (Boston, MA)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more