aiden kelly risk manager johndoegmailcom oxford hybrid summary highly skilled experienced risk manager extensive knowledge iso 13485 qms medical deviceivd product development leading documenting product risk management processes coordinating facilitating across quality regulatory multidisciplinary technical teams adept developing managing process identification management risks outside regular riskfocused sessions ensuring compliance ivd regulatory standards possesses excellent communication interpersonal skills proficient word excel powerpoint etc experience osler risk manager oxford 20182022 planned coordinated risk management activities accordance ivd regulatory standards throughout product development lifecycle created maintained risk documentation within iso 13485 qms across multiple projects jurisdictions worked collaboratively qara rd production drive identification analysis control product risks developed managed process identification management risks outside regular riskfocused sessions resulting effective efficient risk management coordinated facilitated across quality regulatory multidisciplinary technical teams ensure compliance ivd regulatory standards resulting successful regulatory activities market launch osler origin product led documented product risk management processes fmea fta hazard analysis resulting identification control potential product risks medtech innovations quality assurance manager london 20152017 developed implemented quality management systems compliance iso 13485 standards coordinated internal external quality audits ensured compliance regulatory requirements managed capa process ensured timely closure nonconformities developed implemented quality management systems resulting successful certification company iso 13485 standards coordinated internal external quality audits resulting successful audits compliance regulatory requirements managed capa process resulting timely closure nonconformities improved quality metrics biotech solutions quality assurance engineer bristol 2013 2014 conducted quality audits risk assessments identify areas improvement developed implemented corrective preventive actions improve product quality trained employees quality systems regulations conducted quality audits risk assessments resulting identification areas improvement developed implemented corrective preventive actions resulting improved product quality trained employees quality systems regulations resulting increased awareness compliance risk analysis identified mitigated risks multiple projects resulting 20 reduction overall risk strengths collaboration facilitated communication across multidisciplinary teams resulting 15 increase productivity regulatory compliance ensured compliance iso 13485 qms resulting successful product launch regulatory approval wwwenhancvcom powered enhancu