- Philips (Cambridge, MA)
- ** Senior Regulatory Affairs Manager (US Hub based location)** The Senior Regulatory Affairs Manager will develop and communicate a vision ... the area of regulatory submissions. You will manage a Regulatory Affairs team supporting various new and sustaining programs for Philips Ultrasound. **Your… more
- Editas Medicine (Cambridge, MA)
- …way towards a healthier and more equitable future. Position Summary As the Senior Manager of Regulatory Affairs , you will play a critical role in ... registration, and commercialization of our products. Key Responsibilities: As the Senior Manager , Regulatory Affairs , you will be responsible… more
- Fresenius Medical Center (Waltham, MA)
- This position can be fully remote Global Regulatory experience needed. Demonstrated project management experience needed. **PURPOSE AND SCOPE:** Ensures company ... products meet regulatory requirements by supporting all assigned regulatory ...selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of… 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 ... Regular **Scheduled Hours:** 32 **Work Shift:** Rotating (United States of America) The Sr . Regulatory Specialist supports regulatory compliance for clinical… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- The Business Analysis & Operations Senior Manager will drive consistency across the Global Development (GD) IT team & IT community. This role will be a key team ... Research IT teams members. As a Global Development IT Sr Manager (Business Analysis & Operations), a...Clinical Development functions in support of IT - Medical Affairs , Regulatory Affairs , Global Patient… more
- ConvaTec (Lexington, MA)
- …to constantly learn and grow while honing your strategic thinking skills Our successful Director/ Senior Manager Medical Affairs will be involved in all ... and generation of publications. You will have close liaison with Clinical Affairs , Global Education, Regulatory , Quality, Marketing & Business Development and… 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
- embecta (Andover, MA)
- …social channels on LinkedIn , Facebook , Instagram and Twitter . The Senior Manager , Systems Engineering will provide leadership to System Engineering discipline ... R&D organization with a focus on architecture development. The Senior Manager will lead System Engineering team...peer leaders across R&D, Quality, Marketing, Clinical and Scientific Affairs , Operations, Medical Affairs and Regulatory… more
- AbbVie (Worcester, MA)
- …Function within Operations? Look no further! We are currently seeking a dynamic and experienced Senior Manager to lead our Quality team. As the Senior ... product development, Quality Systems, Product QA, Quality Control, Information Systems and Regulatory Affairs and must demonstrate sound judgment in evaluating… more
- embecta (Andover, MA)
- …social channels on LinkedIn , Facebook , Instagram and Twitter . **_The Senior Manager , Systems Engineering will provide leadership to System Engineering ... to act as the hub of product development within the R&D organization._** **_The Senior Manager will lead System Engineering team members and all related activity… 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
- Philips (Cambridge, MA)
- …compliant with internal/external quality/ regulatory standards. **Your role:** + The Senior Program Manager provides program leadership and execution of ... The Senior Program Manager will lead and...will work in a dynamic organization that includes Quality, Regulatory Affairs , Medical Office, Compliance, Quality Services,… more
- Orchard Therapeutics (Boston, MA)
- …Affairs Location: United States, ideally Boston or East Coast Job Summary The Senior Director, Medical Affairs will be a leadership role, accountable for ... People manager role and responsibilities + Post-approval space Medical Affairs activities in the United States + Government and industry guidelines, regulations,… more
- Beth Israel Lahey Health (Beverly, MA)
- …into account other work streams such as IT, HR, medical equipment and regulatory affairs . Oversee establishment of package specific briefs, contracts, as built ... Lahey Health is seeking a dynamic Hospital Construction Project Manager to lead transformative projects for our highly rated...for adherence to set criteria. Monitor and report to senior management on the progress of all project activity,… more
- Blue Cross Blue Shield of Massachusetts (Boston, MA)
- …the organization and corporate strategy. + You will be part of the Government Regulatory Affairs (GRA) Solutions team that oversees all projects within the GRA ... Bring your true colors to blue. What We Need The Senior Project Manager , Scrum Master will be responsible for supporting complex projects/products and… more
- ThermoFisher Scientific (Cambridge, MA)
- …(SUBs), wave reactors preferred. * Demonstrated knowledge of cGMPs/GLP or regulatory affairs pertaining to the pharmaceutical and biological industries ... focused on service delivery excellence for Unity Lab Services (ULS). The Senior Site Specialist will perform process manufacturing duties under the direct… more
- Commonwealth Care Alliance (Boston, MA)
- …duties as assigned. **Secondary Responsibilities** + Contribute towards the overall Department Regulatory Affairs and Compliance infrastructure at CCA. + Promote ... performance indicators **Additional Responsibilities** + Support Corrective Action Plan (CAP) Manager in communicating on new and existing CAPs emerging from source… more
- Veterans Affairs, Veterans Health Administration (Brockton, MA)
- …of the EDRP application. Responsibilities The incumbent serves as the program manager for the Center for Integrated Residential Care for Addictions (CIRCA) which ... practice and is licensed at the advanced practice level. The incumbent program manager provides direct clinical care and will have skills to complete screenings,… more
- Olympus Corporation of the Americas (Westborough, MA)
- … Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... values by staying **True to Life.** **Job Description** The Manager , Senior Global MDR Submission is responsible...review, processing and submission of potential adverse events. The Manager , Sr . Global MDR Submission works closely… more
- Olympus Corporation of the Americas (Westborough, MA)
- … Manager at 1-888-Olympus (###). 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 Sr . Manager , Business Development Quality Assurance will support Quality Assurance M&A… more