- AbbVie (Waltham, MA)
- …to prepare submissions and partic + Makes key decisions on product quality, compliance and regulatory conformance issues for sterile, biological, liquid, solids, ... agreements, contractors or letters of intent to ensure that the appropriate quality, compliance and regulatory aspects are met for the products and services… more
- Fujifilm (Boston, MA)
- …+ Advise, counsel and report to management on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations ... in the development and structuring of new business ventures. + Keep abreast of legislative and regulatory changes that may affect HLUS and its subsidiary companies.… more
- Sanofi Group (Cambridge, MA)
- …legal issues (focusing on antitrust matters, potential litigations and promotional matters, FDA / regulatory issues and fraud and abuse) as well as proposed ... furthers the company's strategic goals while effectively managing legal and regulatory risks and upholding the company's integrity and reputation. Additionally, the… more
- Medtronic (Boston, MA)
- …Regulatory Affairs Specialist, you will play a key role in ensuring regulatory compliance and supporting the global market expansion of products ... submit, and manage regulatory filings across global regulatory agencies based on FDA and EU...changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance . + Monitors and improves tracking… more
- Kelly Services (Marlborough, MA)
- …device or other regulated industries. + Familiarity with ISO standards and regulatory compliance . + Experience with documentation systems and quality management ... suppliers. The ideal candidate will also bring expertise in validation processes and FDA Design Controls and serve as a technical mentor within the organization.… more
- Catalent Pharma Solutions (Chelsea, MA)
- …and quality specialists; + Demonstrate knowledge of International Quality and Compliance standards and requirements, with preferable FDA experience; + ... a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer,... Regulatory Inspections from both EU and US Regulatory agencies such as MHRA, IBM, FDA ,… more
- Integra LifeSciences (Braintree, MA)
- …processes are integrated into the overall process risk management process. ** Regulatory Compliance & Documentation:** + Ensure thorough documentation and ... and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + This position… more
- Takeda Pharmaceuticals (Boston, MA)
- …(SDTM and ADaM), medical terminology, clinical trial methodologies to ensure the compliance with regulatory agencies and data reporting standards; create and ... that can be adapted to multiple studies; Prepare deliverables for regulatory submission to FDA /EMA/PMDA or other agencies (eg eCRTs, ISS, ISE, BIMO, P21 checks)… more
- IQVIA (Boston, MA)
- …to make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. ... Provide strategic and therapeutic area guidance for clinical development plans in compliance with applicable regulatory , medical, and ethics guidelines. + Ensure… more
- Abbott (Westford, MA)
- …high performing team. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... schedules all while enhancing product quality and meeting all compliance requirements. **MAIN RESPONSIBILITIES** + Develop, establish, and maintain strategic… more
Recent Jobs
-
Colony Director (Assistant or Associate Research Professor)
- Emory Healthcare/Emory University (Lawrenceville, GA)
-
Industrial Laborer
- Hall Contracting Of Kentucky (Stovall, GA)
-
Nurse Practitioner or Physician Assistant Internal Medicine
- Provider Solutions & Development (Spokane, WA)
-
Billing Specialist
- HCA Healthcare (Mckinney, TX)