Director of Regulatory and Quality - Danvers Massachusetts

Company: Michael Page
Location: Danvers, Massachusetts
Posted On: 05/02/2024

Reporting into the General manager, The Director of Quality & Regulatory will direct the organisation's Regulatory Affairs and Quality Assurance functions in multiple areas including documentation, compliance, audits and regulatory submissions.Client DetailsOur client manufactures and markets precision laser systems, imaging systems, consumables, software, and services that reduce cost, increase productivity, improve results, and enable breakthroughs in Fertility Research Markets. Their customer base consists of clinics, university research centers, and other commercial and academic research establishments.DescriptionThe responsibilities of the Director of QA/RA are

• Direct and oversees all US and international regulatory submissions.
• Manages responses as requested by regulatory agencies or agents.
• Oversees and ensures compliance of MDD technical files and related documentation.
• Oversee Quality Assurance Functions supporting on-site Manufacturing
• Responsible for developing and and reporting quality metricsA full job description will be sent after assessment of candidate's credentials. ProfileThe successful Director of Quality & Regulatory will have
  • Minimum of Bachelor's degree for education
  • Minimum of 5 years working experience in the medical device field
  • Knowledge of electromechanical equipment will be preferable
  • Experience wearing "multiple hats" within Quality & Regulatory department Job OfferMy client offers a competitive, base, bonus potential, and excellent benefits. Each resume will be reviewed in 24-48 hours and relevant applicants will be scheduled immediately for a discussion. MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. More...

        

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