applicable safety, EMC, regulatory, and quality requirements throughout the product development lifecycle. Required Experience...
, therapeutic mechanisms, and regulatory developments Translate technical and scientific information into clear, accurate... with regulatory pathways (FDA, EMA) and trial registries (e.g., ) ALS-TDI is an equal opportunity employer. We celebrate diversity...
and collaborate with external auditors Support internal controls and ensure adherence to regulatory compliance Required Experience...
. Provide technical expertise for regulatory submission relevant to statistical programming deliverables. Support the function..., regulatory submission and SAS coding. 2. Help function director manage resources, timelines, and assignments for a single...
with a strong autonomous background in project management, as well as a deep understanding of the medical device industry and regulatory... and improve project performance and implement best practices. Ensure compliance with all relevant regulatory requirements...
regulatory inspections and audits as required. Maintain awareness of project schedules and strive to achieve whilst responding...
’s consent or knowledge. All roles at Naveris require compliance with legal and regulatory requirements of HIPAA and acceptance...
and collaborate with external auditors Support internal controls and ensure adherence to regulatory compliance Required Experience...
management, work management, regulatory compliance). Knowledge of Maximo Application Suite (MAS) and its key functionalities...
candidates and (2) communicate strategies and findings internally and to regulatory authorities globally. The Associate Director... is the single point of accountability within NSE for all strategic, scientific, study-related, and regulatory aspects of the...
quarterbacking the team, providing patients with meaningful counseling, and abiding by all legal and regulatory guidelines, amongst...
discipline required General knowledge of compliance requirements for FDA regulatory medical devices Demonstrated ability...
, governance, and ways of working Increase speed‑to‑market while maintaining technical, regulatory compliance..., Engineering &; Supply Chain Food Safety and Quality, Regulatory &; Sustainability External partners...
engineering file documentation in alignment with regulatory standards (e.g., IEC 62366, MDR, FDA Guidance) Collaborate globally... that include both hardware and software components Strong knowledge of medical device usability standards and regulatory...
. Serve as a key partner to regulatory policy team providing strategic counsel on advocacy opportunities, and stakeholder...
pharmaceutical industry, including academic and industrial partners, competitors, and regulatory agencies. Essential Skills...
engineering file documentation in alignment with regulatory standards (e.g., IEC 62366, MDR, FDA Guidance) Collaborate globally... that include both hardware and software components Strong knowledge of medical device usability standards and regulatory...
's business objectives, regulatory requirements, and evolving threat landscape while continuously improving the organization...
or services information with customers or patrons. Prepare documentation for contracts, transactions, or regulatory compliance...
and familiarity with Healthcare Professionals (HCPs) and relevant regulatory reporting requirements. Working knowledge of SAP Concur...