- Philips (Cambridge, MA)
- …role you have the opportunity to** Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory ... US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. **Your role:** + Serve as RA Representative on project teams,… more
- Actalent (Bedford, MA)
- …design and risk management teams (both Hemostasis and Acute Care) as the regulatory representative and provide guidance on China NMPA and Japan PMDA requirements, ... including: Author and sign Regulatory Plans on regulatory requirements for worldwide submissions for new products and significant post-market modifications as… more
- Philips (Cambridge, MA)
- …or external quality system audits. + Reporting to the Director of Regulatory Affairs , the Senior RA Specialist will collaborate with global team members, ... claim landscape, legislative initiatives, and marketing strategy. **Your role:** + The Senior RA Specialist provides the regulatory plan, guidance… more
- Merck (Boston, MA)
- **Job Description** The Senior Professional Services Veterinarian- Dermatology Specialist will function to support the commercial, medical, and business needs of ... may include, but are not limited to: + Utilizes specialist knowledge and experience in dermatology to serve as...leaders of diverse expertise and backgrounds, and assist medical affairs in developing and guiding advisory boards + Represent… 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) ... The Sr. L&D Specialist , Global QMS Training will serve as a senior individual contributor within Quality. This individual will support the management of the… more
- ThermoFisher Scientific (Cambridge, MA)
- …(SUBs), wave reactors preferred. * Demonstrated knowledge of cGMPs/GLP or regulatory affairs pertaining to the pharmaceutical and biological industries ... on service delivery excellence for Unity Lab Services (ULS). The Senior Site Specialist will perform process manufacturing duties under the direct supervision of… more
- Pine Street Inn (Jamaica Plain, MA)
- Senior Housing Compliance Manager Department: Supportive Housing - Property Management Office: 82 Green Street Location: Jamaica Plain, MA Position Type: Management ... 82 Green Street, Jamaica Plain, MA JOB DESCRIPTION: SUMMARY OF POSITION: The Senior Housing Compliance Manager for Pine Street Inn, Inc. provides oversight of… 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
- Takeda Pharmaceuticals (Cambridge, MA)
- …chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs , to develop and implement effective process ... + Identifies topics for initiatives and leads local/global initiatives on behalf of senior staff. + Recognized as a technical leader/resource by the group and… more