- Regeneron Pharmaceuticals (Cambridge, MA)
- …will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory standards such as 21 CFR ... **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part of Regeneron… more
- Nanobiosym, Inc. (Cambridge, MA)
- …+ Prior in-house legal experience in a biotech or pharmaceutical company. + Familiarity with regulatory frameworks (eg, FDA , EMA) as they relate to IP. ... matters, including licensing agreements, collaborations, M&A due diligence, and regulatory submissions. + Dispute Resolution: Support IP litigation, opposition… more
- Integra LifeSciences (Braintree, MA)
- …to resolve environmental control issues. + Ensure compliance with safety, environmental, and regulatory standards (eg, FDA , ISO). + Maintain accurate records of ... management systems (BMS) and automated environmental controls. + Knowledge of regulatory requirements in the medical device or pharmaceutical industry. + Experience… more
- Fresenius Medical Center (Waltham, MA)
- …device sector or related industries + Several years of practical experience in FDA inspections and cooperation with US regulatory authorities (experience with ... activities are in compliance with FME policies and procedures and applicable regulatory requirements + Develop and maintain audit processes and documentation to… more
- Medtronic (Boston, MA)
- …product approvals. Prepare, submit, and manage regulatory filings across global regulatory agencies based on FDA and EU submissions. Provide expertise on ... world. **A Day in the Life** Job Summary: Principal Regulatory Affairs Specialist As a Principal Regulatory Affairs Specialist, you will play a key role in… more
- Bristol Myers Squibb (Devens, MA)
- …resources at all levels. + Demonstrated hands on supplier management implementation in regulatory agencies like: FDA , ANVISA, COFEPRIS, EMEA, BfArM, JP, MHRA ... among others. + Ability to communicate effectively within a matrix organization. + Effective at selling ideas, services and solutions to others at different organizational levels and functions. + Demonstrates leadership, interpersonal, communication, and… more
- Teleflex (Chelmsford, MA)
- …implementation, and maintenance of the quality management system (QMS) in compliance with regulatory requirements (eg, FDA , ISO 13485). *Backup support for the ... training associate. *Collect, analyze and report quality metrics to drive continuous improvement *Ensure compliance with regulations, laws and guidelines *Perform additional duties as assigned This position requires direct contact with an implantable device. ☐… more
- Integra LifeSciences (Braintree, MA)
- …and analyze process data. + Assist in preparing for, and participating in FDA audits, internal audits, and other regulatory agencies audits. + Demonstrate ... years GMP/GLP laboratory experience in a medical device, pharmaceuticals, Quality/ Regulatory Compliance, or other regulated industry + Familiarity with application… more
- Rise Baking Company (Worcester, MA)
- …experience + 5+ years of management/supervisory experience + Proficient knowledge of regulatory disciplines (EPA, OSHA, FDA , USDA) + Strong employee and ... employee and consumer safety-first culture and support all guidelines of GMPs, HARPC, FDA , the Environmental Control Act, and OSHA standards to ensure safe and… more
- Cambrex High Point (Waltham, MA)
- …manufacturing and tech transfer of peptide APIs. + Strong understanding of regulatory guidelines (ICH Q8/Q9/Q11, FDA /EMA expectations) and process validation. + ... reports, batch records, validation protocols, CMC documentation (eg, Module 3), and regulatory filings (IND, NDA). + Collaborate cross-functionally with QA, QC, … more