- Spindrift (Newtonville, MA)
- …agreements, sustainability matters, website copy and marketing materials + Advise on FTC, FDA , and related regulations for food & beverage products + Mitigate risks ... integrations), and website content + Advise on consumer data privacy, including compliance with applicable laws (eg, CCPA, CPRA, GDPR) + Collaborate with Tech… more
- Integra LifeSciences (Boston, MA)
- …Action/Preventive Actions (CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties as assigned. **DESIRED ... of 2-4 years' experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance , or other cGMP regulated product preferred environment. + Familiarity… more
- Sanofi Group (Cambridge, MA)
- …clinical trials, marketing strategies, and key publications. + **Regulatory and Compliance Oversight** : Oversee the medical review and approval of regulatory ... written communication skills. + Strong understanding of clinical trials processes and FDA approval processes, including accelerated approval, and FDA and other… more
- IQVIA (Boston, MA)
- …make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. Experience ... strategic and therapeutic area guidance for clinical development plans in compliance with applicable regulatory, medical, and ethics guidelines. + Ensure… more
- Takeda Pharmaceuticals (Boston, MA)
- …proposed. + The Sr Director/Director will be accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports ... responsible. + Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. + Leads the GRT and… more
- Integra LifeSciences (Braintree, MA)
- …Process Validation, or other studies as deemed necessary. + Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal ... support development and sustaining/remediation projects. + Maintain all projects are in compliance with GMP, QSR, ISO or other applicable requirements. + Identify… more
- Danaher Corporation (Waltham, MA)
- …and stay aligned with relevant laws and regulations, including healthcare compliance (eg, Anti-Kickback Statute), FDA regulations, anti-corruption (eg, FCPA), ... Caribbean. This role provides legal guidance on a wide range of commercial, compliance , and regulatory matters, with a particular focus on Latin America. The Legal… more
- Cardinal Health (Boston, MA)
- …hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory/ compliance and contract manufacturing. **_Responsibilities_** + Demonstrate strong ... + Handle fast paced and high-volume workload + Identify legal and compliance issues and business risks and escalate appropriately + Effectively communicate with… more
- Sanofi Group (Cambridge, MA)
- …including email monitoring, live monitoring activities, and other projects in compliance with pharmaceutical industry regulations and company policies. As a Monitor ... the Ethics & Business Integrity department at Sanofi, you will lead compliance monitoring activities within the US Monitoring Team. This pivotal role collaborates… more
- AbbVie (Waltham, MA)
- …are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. ... for further packaging and/or testing. Primary driver for the quality and compliance + Develops Global Product Quality Assurance strategy and implements agreed… more