- CVS Health (Wellesley, MA)
- …reviewing product labels, marketing claims, and promotional campaigns to ensure legal and regulatory compliance with FDA and FTC requirements, as applicable. ... You will be primarily responsible for the legal and regulatory review of new and innovative products, from concept...labeling and marketing claims for truthfulness and accuracy and compliance with laws and regulations, including FDA ,… more
- Hologic (Marlborough, MA)
- …in clinical research or R&D. + Expertise in clinical study design, evidence generation, and regulatory compliance (eg, FDA , ISO, GCP). + Strong knowledge of ... working cross-functionally to generate high-quality clinical evidence that supports regulatory clearance, market adoption, and business growth. **Key Responsibilities:**… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Compliance Head- US FDA **Location** : Framingham, MA, Morristown, NJ **Job Title:** Compliance Head- US FDA **Location** : Framingham, ... technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded… more
- Tecomet (Woburn, MA)
- …Serve as Official FDA Correspondent. + Serve as person responsible for regulatory compliance (PRRC). + Assist and complete site FDA /ISO/AS/EAR ... and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This... governance + Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market… more
- Actalent (Waltham, MA)
- …electrophoresis, PCR, and protein assays. + Proficiency in ELISA, protein chemistry, and regulatory compliance (eg, FDA guidelines). + Demonstrated ability ... to troubleshoot and optimize analytical methods. Qualifications: + PhD in a relevant scientific discipline with5+ years of experience, or + Master's degreewith7+ years, or + Bachelor's degreewith10+ years of relevant experience. + Proven experience mentoring… more
- Actalent (Waltham, MA)
- …withHPLC,capillary electrophoresis,PCR, andprotein assays. + Proficiency inELISA,protein chemistry, and regulatory compliance (eg, FDA guidelines). + ... Demonstrated ability to troubleshoot and optimize analytical methods. Qualifications: + PhDin a relevant scientific discipline with5+ yearsof experience, or + Master's degreewith7+ years, or + Bachelor's degreewith10+ yearsof relevant experience. + Proven… more
- Actalent (Lexington, MA)
- …mentorship to QA staff Core Skills: + Quality Assurance and regulatory compliance + Audit management and FDA interaction + CAPA development and ... (QA) team, overseeing all aspects of quality systems and regulatory compliance . This role is responsible for...the Quality Assurance team and daily operations + Ensure compliance with FDA regulations, GMP, GxP, and… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal ... work with amazing partners, including other Harvard Medical School-affiliated hospitals. ** Regulatory Compliance ** + Prepares and submits all protocol… more
- Takeda Pharmaceuticals (Boston, MA)
- …the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. + ... maintain compliance for products. + Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. + Participates with… more
- Philips (Cambridge, MA)
- …Products meet FDA , and other governmental agency/notified body Regulatory Compliance standards/requirements. **Your Role:** + Leads business critical ... protocols. + Providing guidance on current, new and updated Regulatory compliance procedures globally, such as CE...and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA 's guidance documents, and including… more