- Tecomet (Woburn, MA)
- …improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This is accomplished by maintaining Tecomet principles ... Design Dossiers and Change Notices. + Serve as Official FDA Correspondent. + Serve as person responsible for regulatory...for regulatory compliance (PRRC). + Assist and complete site FDA /ISO/AS/EAR Registrations + Host FDA and government… more
- CVS Health (Wellesley, MA)
- …initiatives. + Initiative, drive and self-confidence. + Expertise in FDA regulation, including product clearances and approvals, reporting requirements, recalls, ... promotional campaigns to ensure legal and regulatory compliance with FDA and FTC requirements, as applicable. + Ability to...on bringing new and innovative products to market, including FDA product clearances and approvals. + Consult on strategic… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate ... regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares, maintains and organizes Regulatory… more
- Hologic (Marlborough, MA)
- …representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market. This is a ... Regulatory teams to provide security input for audits and FDA submissions. + Maintain current knowledge of FDA... FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards,… more
- Takeda Pharmaceuticals (Boston, MA)
- …of technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports ... types such as original NDA/BLAs. + Direct point of contact with FDA , leads and manages FDA meetings. Manages direct reports or junior staff as needed. +… more
- Sanofi Group (Cambridge, MA)
- …action, competitively positions assigned products and is consistent with applicable FDA regulations and company policies for advertising and promotion of ... Provision of competitively positioned promotional materials that comply with applicable FDA and corporate regulations, policies and guidance + Analyze whether… more
- Takeda Pharmaceuticals (Lexington, MA)
- …the following duties: Write Validation documents per Food Drug Administration ( FDA )/Company guidelines; draft Specification documents and Validation Plans (VPs) for ... for new and existing equipment or procedures in accordance with company and FDA regulations; define and own all necessary change control objectives to decommission… more
- Philips (Cambridge, MA)
- …development projects, ensuring our state-of-the-art Ultrasound Products meet FDA , and other governmental agency/notified body Regulatory Compliance ... 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA 's guidance documents, and including requirements that are relevant to the overall… more
- Pfizer (Andover, MA)
- …within budget. Ensure all computerized systems comply with regulatory requirements, including FDA 21CFR820, FDA 21CFR11, GAMP, and other applicable regulations. ... experience implementing CSV activities to support GxP systems. + Strong knowledge of FDA and cGMP regulations and documentation practices. + Strong knowledge of GAMP… more
- Takeda Pharmaceuticals (Boston, MA)
- …of technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports ... point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as...of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a plus. +… more