- 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 ... Multiple experience in preparing and interacting with multiple regulatory agencies including FDA , EMA, and others + Multiple NDA/MAA submission experience + Proven… more
- J&J Family of Companies (Danvers, MA)
- …Quality & Regulatory Compliance** + Maintain alignment with regulatory expectations (eg, FDA QSR/21 CFR Part 820, ISO 13485) and support regulatory submissions as ... operations within medical devices or complex product environments. + Deep understanding of FDA QSR/21 CFR Part 820 and ISO 13485. + Experience with design controls,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance & Risk Management** + Monitor training compliance ... + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver impactful learning programs… more
- Beth Israel Lahey Health (Burlington, MA)
- …medical conditions and diagnoses. **Job Description:** 1) Possesses ongoing knowledge of FDA , OHRP and GCP regulations: + Ensures adherence to regulations. + ... + Implements all study protocols in accordance with research SOPs, FDA , OHRP, and GCP regulations. + Immediately develops coordinator/sponsor relationship. +… more
- Integra LifeSciences (Braintree, MA)
- …Process Validation, or other studies as deemed necessary. + Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal ... + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of TrackWise preferred. + Knowledge of Agile product lifecycle… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …for test equipment, calibration requirements, and verification procedures in alignment with FDA and QSR standards. + Develop and execute validation plans for service ... industrial environment preferred + Experience working in a regulated environment; knowledge of FDA QSR and ISO 13485 preferred preferred + Familiarity with Lean, Six… more
- Nanobiosym, Inc. (Cambridge, MA)
- …Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission + Manage and contribute to regulatory documents + Project ... managerial and leadership expertise in assay development + Strong understanding of FDA and global regulatory requirements + Prefer commercial assay experience +… more
- J&J Family of Companies (Boston, MA)
- …while professionally representing the company. + Comply with all corporate compliance, FDA , medical device, quality standards and ethics. + Other duties as assigned. ... 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
- Nanobiosym, Inc. (Cambridge, MA)
- …steps. + Develop and implement validation protocols (IQ/OQ/PQ) that comply with FDA regulations. + Provide troubleshooting focus and direction for the team with ... statistical process control + Recent experience with medical device development, in an FDA regulated (21 CFR 820) and/or ISO 13485 environment + Strong written and… more
- Carrier (Beverly, MA)
- …+ Interpret and monitor global regulatory requirements (eg, CE/MDR, FDA , ISO standards, environmental/transport regulations, wireless communications, data security). ... Certification (RAC) or equivalent professional certification + Regulatory Knowledge on US: FDA , FCC; EU: MDR, Radio Equipment Directive, Low Voltage, EMC; Canada,… more