- Tecomet (Woburn, MA)
- …and communicate the training initiatives and document control and records to ensure compliance to FDA , Global Regulatory bodies and ISO requirements. Training ... the organization, maintenance and storage of all documents related to FDA /ISO compliance , DMRs, DHRs, DCNs, and Management Review Records. + Maintains… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and NDA/IND commitments + Act as an expert resource for eCTD submissions to FDA , ensuring compliance with internal and health authority standards + Support the ... new or revised regulatory policies and initiate activities to support compliance + Participate in special projects and process improvement initiatives Qualifications… more
- Tecomet (Wilmington, MA)
- …create, monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This is accomplished by ... Correspondent. + Serve as person responsible for regulatory compliance (PRRC). + Assist and complete site FDA... compliance (PRRC). + Assist and complete site FDA /ISO/AS/EAR Registrations + Host FDA and government… more
- Philips (Cambridge, MA)
- …new product development projects, ensuring our state-of-the-art Ultrasound Products meet FDA , and other governmental agency/notified body Regulatory Compliance ... ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA 's guidance documents, and including requirements that are relevant to the… more
- J&J Family of Companies (Boston, MA)
- …moral character while professionally representing the company. + Comply with all corporate compliance , FDA , medical device, quality standards and ethics. + Other ... conjunction with near-term plans to further business goals. + Must not be debarred by FDA for work in any Medical Device business. + Ability to work in a fast-paced… more
- Hologic (Marlborough, MA)
- …you will define, implement, and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory ... MA, United States Are you a seasoned quality and compliance professional with a passion for driving excellence in...patient safety and innovation. **Knowledge** + Deep understanding of FDA Code of Federal Regulations (21 CFR 820), ISO… more
- ARAMARK (Boston, MA)
- …operations councils and workgroups. + Helps prepare, develop and execute action plans on FDA , Business Process Compliance and Wage and Hour Audits. + Maintains ... to ensure operational excellence accordance with all established business process compliance SOPs. Ensures daily operations are maintained as scheduled. + Assists… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …security policies, standards, and best practices + Conduct risk assessments and manage compliance with FDA , HIPAA, SOX, GDPR, and other regulations + Lead ... leader who can collaborate cross-functionally, navigate a regulated environment ( FDA , HIPAA, GDPR), and scale enterprise-wide technology systems globally.Essential… more
- Nanobiosym, Inc. (Cambridge, MA)
- …and functional testing. + Support regulatory and quality processes with a focus on FDA and ISO 13485 compliance . Minimum Qualifications: + Master's Degree in ... experience in product development environments. + Strong understanding of compliance standards in regulated industries (eg, FDA ,...of compliance standards in regulated industries (eg, FDA , ISO 13485). + Proven track record of delivering… more
- System One (Devens, MA)
- …of GMP requirements + Maintain accurate documentation of all production processes in compliance with FDA cGMPs, DEA regulations, and company SOPs + Partner ... seasoned professionals with GMP/CDMO experience who can lead by example, drive compliance , and motivate teams in a high-performing, fast-paced environment. If you're… more