- Hologic (Marlborough, MA)
- …product lifecycle. As a subject matter expert, you will partner with R&D, Regulatory Affairs , and Manufacturing Engineering teams to embed quality and compliance ... requirements traceability. + Familiarity with Good Laboratory Practices and global regulatory requirements for medical devices. + Proficiency in statistical methods,… more
- Beth Israel Lahey Health (Plymouth, MA)
- …conflict resolution + Prior experience in direct responsibility for regulatory affairs and claims management strongly preferred **Registration/Certification:** ... Massachusetts DPH, the Boards of Registration in Medicine and Nursing, and other regulatory agencies as needed. In particular lead the investigation and response to… more
- ThermoFisher Scientific (Waltham, MA)
- …with us. This role is located in Waltham, MA within the dynamic Corporate Quality & Regulatory Affairs team. You will be part of a diverse and inclusive team ... passionate about world-class regulatory compliance and quality standards. **Discover Impactful Work:** Join...Impactful Work:** Join us in making a difference! As aQ& RA Coordinator - Project Manager I, you will meticulously… more
- Takeda Pharmaceuticals (Boston, MA)
- …functions across Takeda Oncology including Translational Medicine, Clinical Sciences, Global Regulatory Affairs , the Oncology Business Unit (Commercial and ... and external diagnostic partners, and supporting health authority meetings and regulatory submissions (PMAs etc). This role will partner closely with key… more
- Lilly (Boston, MA)
- …being accountable for submissions, and taking part in meetings. + Represent the regulatory affairs team on cross-functional project teams and provide guidance to ... in Boston, Massachusetts. **The Position** The purpose of the Associate Director, Regulatory Strategy role is to support the development and implementation of… more
- Staples (Framingham, MA)
- …Basic Qualifications** : + Bachelor's degree in Quality Management, Engineering, Supply Chain, Regulatory Affairs , or related field. + 8+ years of experience in ... safety programs. + Developing and enforcing policies that ensure products meet regulatory requirements and company specifications. + Leading root cause analysis and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …when applicable through close collaboration with cross-functional teams (including Medical Affairs , Clinical Development, Regulatory Affairs , Commercial, GPD ... Expertise:** + Comprehensive understanding of the pharmaceutical industry and medical affairs + Global regulatory expertise with demonstrated strong ability… more
- Rhythm Pharmaceuticals (Boston, MA)
- …collaboratively with key inter-disciplinary stakeholders (eg biostatistics, clinical development and regulatory affairs ) to drive the generation of actionable ... Data Science to lead data-driven initiatives in support of our clinical, regulatory , and scientific objectives. The successful candidate will have a strong… more
- Bristol Myers Squibb (Devens, MA)
- …Science and Technology, Business Process Management, Internal and External Manufacturing, Regulatory Affairs , Brand Teams, Legal, Patient Safety, Medical ... all cell therapy operations-spanning development and commercial programs-meet or exceed regulatory and internal quality requirements. The Head of Cell Therapy… 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