Director of Regulatory Affairs - Medical Device

  • Michael Page
  • Boston, MA, USA
  • Jan 15, 2020
Full time Executive

Job Description

The Director of Regulatory Affairs-Medical Device will lead regulatory affairs strategies to achieve FDA and international regulatory approvals of Class II/III applications. This individual will serve as a "player-coach" expected to lead from the front while managing and mentoring junior RA staff members. Client DetailsOur latest client is a medical device manufacturer based in the Greater Boston Area. While the company is established, its operations run very much so in comparison to a "start-up" environment where everyone "wears many hats." This organization recently has gone public and obtained multiple FDA approvals for its devices. DescriptionLead strategies to achieve FDA and international regulatory approvals of Class II/III applicationsPrepare and review FDA and international applications and other regulatory documents including EU Technical Files, PMAs and PMA Supplements, Investigational Device Exemptions (IDEs) and IDE Supplements, Annual Reports for PMAs and IDEs and Medical Device reports (MDRs)Review and interpret regulatory rules as they relate to company procedures, clinical studies, engineering testing, and documentation and ensure that they are communicated through company policies and proceduresServe on product development and engineering teams to ensure that RA requirements are fully understood and mitigated as part of the product development and the engineering change processManage and mentoring junior RA staff members up to sustainability ProfileBachelor's degree in engineering or technical degree required, Masters or PhD. preferred10 years of Class III regulatory affairs experience in medical device industryMust have proven track record in successful regulatory submissions in the US and internationallyJob OfferStrong base salaryStrategic role expected to be key decision maker in Regulatory AffairsManagement role with direct reportsCompetitive benefits package Rapidly growing company - recently made IPO and has had FDA approvals for multiple devicesVisibility to senior leadershipAmple opportunity for promotions and growthMarket leader within its medical device type Key needs:5 years' experience in regulatory affairs within the medical device industry Strong experience in EU Regulations is required Experience in FDA submissions requiredCandidate Education:B.S. in a technical discipline requireCandidate Experience:5 years' experience in regulatory affairs within the medical device industry or life sciencesExperience in FDA submissions required