... technical documents.brServes as a Regulatory Affairs subject matter expert on ... geography and generate the required regulatory submission (including Letters To File) ... to allow presentation of complex regulatory strategies in a clear, concise, ...
... .brAssists in the development of Regulatory Affairs processes.brThe anticipated base ... of 4+ years of related Regulatory Affairs experience within Medical Device ... to allow presentation of complex regulatory strategies in a clear, concise, ...
... understanding of quality systems and regulatory requirements.brKeep abreast of regulatory changes and industry best practices ... updates.brManage relationships with external regulatory agencies and auditors, supporting inspections ...
... with the companys objectives and regulatory guidelines.brStay up to date ... adherence to all relevant GMP regulatory requirements (FDA, EMA, etc.), industry ... issues.brManage relationships with external regulatory agencies and auditors, leading inspections ...
... , cGMP, EHS, and other regulatory requirements.Practice proactive environmental monitoring ... .Understand and support current regulatory trends and future testing requirements. ... knowledge of FDA EMEA regulatory requirements for biologics and pharmaceuticals. ...
... corporate, cGMP, EHS, and other regulatory requirements.Ensure that all activities ... meet the business needs and regulatory requirements.Pursue opportunities to develop ... -depth knowledge of FDA EMEA regulatory requirements applicable to biologics and ...
... corporate, cGMP, EHS, and other regulatory requirements.Ensure that all activities ... meet the business needs and regulatory requirements.Pursue opportunities to develop ... -depth knowledge of FDA EMEA regulatory requirements for biologics and or ...
... Engineers, Development Engineers, Quality Engineers, Regulatory Affairs, Marketing, and Clinical.Meet ... experiences.Knowledge of FDA or regulatory guidance.Medical related experience (previous ...
... intended use and follow applicable regulatory requirements (e.br.brcG(a) ... most complex assessments to determine regulatory compliance and any necessary improvements ...
... corrective actions, and ensure timely regulatory reporting.Stay updated on EHS ... program implementation.Ability to interpret regulatory issues and develop solutions for ...