- GE Vernova (Boston, MA)
- …testing and qualification. + Experience in US and international nuclear regulatory affairs , licensing, laws, rules, regulations, guidance, etc. applicable ... applicable nuclear guidance, and industry standards. + Remain current on nuclear regulatory issues and system, component, and equipment product knowledge. + Use… more
- GE Vernova (Boston, MA)
- …seismic testing and qualification + Experience in US and international nuclear regulatory affairs , licensing, laws, rules, regulations, guidance, etc. applicable ... applicable nuclear guidance, and industry standards + Remain current on nuclear regulatory issues and system, component, and equipment product knowledge + Use… more
- Candela Corporation (Marlborough, MA)
- …improvement actions related feedback. . Jointly accountable with Quality System (QS) and Regulatory Affairs (RA) Leadership for ensuring the QS is effectively ... at least 12 years in a management/leadership role in quality / regulatory / compliance. . Working understanding of relevant global/regional medical device… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs . + SME for Takeda drug product manufacturing organization ... and the life cycle management of existing products. You will lead regulatory interactions, including the preparation of Chemistry, Manufacturing, and Controls (CMC)… more
- Fallon Health (Worcester, MA)
- …and correspondence with internal business owners, Compliance, IT Security, MassHealth, SCO, Regulatory Affairs and legal counsel as appropriate. + Work ... + Ongoing vendor management to ensure all contract terms and conditions including regulatory and compliance related requirements are being met. + Perform all aspects… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …**Global Collaboration & Stakeholder Engagement** + Partner with stakeholders across Regulatory Affairs , Clinical, Manufacturing, Compliance, and IT to align ... excellence roles. + Solid understanding of GxP principles and global regulatory expectations. + Experience supporting audit or inspection readiness programs. +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …clinical biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and ... issues to management as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase the external recognition of… more
- Beth Israel Lahey Health (Plymouth, MA)
- …conflict resolution + Prior experience in direct responsibility for regulatory affairs and claims management strongly preferred **Registration/Certification:** ... involved in legal proceedings. + Act as the primary hospital contact for regulatory agencies, including the Massachusetts DPH, the Boards of Registration in Medicine… more
- Commonwealth Care Alliance (Boston, MA)
- …+ Coordinate with other CCA departments, including Clinical Management, Member Services, Regulatory Affairs , Claims and Outreach and Marketing, to resolve ... service recovery; Program benefits; Clinical initiatives; Referral and authorization; Regulatory compliance; Billing and payments; Complaints and appeals; Policies… more
- Oracle (Boston, MA)
- …expand long-term relationships with senior-level stakeholders across Commercial, Medical Affairs , Clinical Development, Regulatory , and Safety organizations. + ... to drive growth across **Commercial, Real-World Evidence (RWE), Clinical, Regulatory , and Safety research services** within pharmaceutical and biotechnology… more