- 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
- Nanobiosym, Inc. (Cambridge, MA)
- …is responsible for the organization and the coordination of processes pertaining to regulatory compliance and quality systems to ensure regulatory ... including the creation and documentation of validation protocols that comply with FDA regulations. + Provide troubleshooting focus and direction for the team with… more
- Cardinal Health (Boston, MA)
- …IDNs, hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory / compliance and contract manufacturing. **_Responsibilities_** + Demonstrate ... collaborate with subject matter experts from other departments, especially the Legal, Regulatory Counsel and Compliance teams + Demonstrate knowledge of general… more
- ThermoFisher Scientific (Plainville, MA)
- …biologics, pharmaceuticals, or cell and gene therapy sectors + Consistent record handling regulatory inspections ( FDA , EMA, Health Canada) + Proven success in ... operations. The manager collaborates closely with GMP and Operations to uphold compliance and product integrity. **Key Responsibilities:** Lead a team of quality… more
- Sanofi Group (Cambridge, MA)
- …strategic business support to maintain Sanofi's commitment to ethical practices and regulatory compliance . We are an innovative global healthcare company with ... + Execute email monitoring program across multiple Business Units to ensure compliance with regulatory requirements, internal policies, and product messaging +… more
- Merck (Boston, MA)
- …including response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for ... aimed at answering customer and industry questions, monitoring protocol compliance , and summarizing results from post-approval marketing support trials specific… more
- Integra LifeSciences (Braintree, MA)
- …+ 5+ years GMP/GLP laboratory experience in a medical device, pharmaceuticals, Quality/ Regulatory Compliance , or other regulated industry + Familiarity with ... or improved quality control systems as needed. + Ensure compliance with industry regulations, company policies, and safety standards...data. + Assist in preparing for, and participating in FDA audits, internal audits, and other regulatory … more
- Integra LifeSciences (Braintree, MA)
- …A minimum of 2-4 years' experience in a medical device, pharmaceuticals, Quality/ Regulatory Compliance , or other cGMP regulated product preferred environment. + ... US Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. **ESSENTIAL DUTIES AND… more
- Fresenius Medical Center (Lawrence, MA)
- …ensure product quality and minimize risk to users and patients as well as regulatory and corporate SOP compliance . . Reviews and approves design control ... and Regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning and implementation of risk… more
- Medtronic (Boston, MA)
- …requirements for business continuity, operations security, cryptography, forensics, regulatory compliance , internal counter-espionage (insider threat detection ... the team, you will provide expertise in risk management, compliance , and security strategy, while also playing a key...regulations and standards specific to the medical device industry ( FDA , HIPAA, IEC 62443, NIST, NIS 2, etc.). +… more