- Tecomet (Woburn, MA)
- …as Official FDA Correspondent. + Serve as person responsible for regulatory compliance (PRRC). + Assist and complete site FDA /ISO/AS/EAR Registrations + ... **TITLE** : Quality Assurance & Regulatory Affairs Manager **Department:** Quality Assurance / ...Host FDA and government and notified regulatory agencies audits. + Review and interpret regulatory… more
- Hologic (Marlborough, MA)
- …input for audits and FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, ... regulated environment is required. + Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST,… more
- Abbott (Burlington, MA)
- …determine if a medical device report needs to be filed with various global regulatory agencies (eg, FDA , European Competent Authorities) and sends reports within ... regulatory requirements. Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating… more
- Fresenius Medical Center (Waltham, MA)
- …commercialization of pharmaceutical products. + Ensure compliance with local and global regulatory standards, including FDA , EMA, ICH, and other regulatory ... AND SCOPE:** Responsible for leading the strategic direction and execution of regulatory strategies for our global pharmaceutical portfolio. This position plays a… more
- Sanofi Group (Cambridge, MA)
- …on organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling ... **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy **Location** :...in helping our teams accelerate progress. The Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for… more
- Spindrift (Newtonville, MA)
- …law, trademark/IP, employment law, and privacy/data protection + Familiarity with FDA /FTC regulatory frameworks for food/beverage marketing + Excellent judgment ... agreements, sustainability matters, website copy and marketing materials + Advise on FTC, FDA , and related regulations for food & beverage products + Mitigate risks… more
- TEKsystems (Boston, MA)
- …Python, or similar scripting languages + Familiarity with GMP, GAMP, and FDA regulatory environments + Excellent communication, problem-solving, and project ... management skills Preferred Experience + Experience with Oracle ERP, Aveva PI, or similar platforms + Prior work in pharmaceutical or animal health manufacturing + Knowledge of lean manufacturing and Six Sigma methodologies Pay and Benefits The pay range for… more
- Sanofi Group (Cambridge, MA)
- …endpoint strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, ... instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research...asset and indication strategy meeting, as well as in FDA meetings on invitation. + The Senior COA Lead… more
- Abbott (Westford, MA)
- …high performing team. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... priority within manufacturing and that product meets all design, manufacturing, and regulatory requirements. + Ensure a safe work environment consistent with OSHA… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Oversees and leads all clinical science activities involved in interactions with FDA , other regulatory agencies and key opinion leaders relevant to assigned ... development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency… more