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Regulatory Affairs / Quality Assurance Associate

Company: Hamilton Thorne
Location: Beverly
Posted on: June 25, 2022

Job Description:

We are constantly looking to add to our core talent. If you are seeking a career that is rewarding and challenging, take a moment to apply! We are adding to our Regulatory team! Paralegal backgrounds are strongly encouraged to apply!Hamilton Thorne, Inc. (HTI) manufactures and markets precision laser systems, imaging systems, consumables, software, and services that reduce cost, increase productivity, improve results, and enable breakthroughs in Assisted Reproductive Technologies (ART) and developmental biology research markets. HTI's customer base consists of fertility clinics, university research centers, animal breeding facilities, pharmaceutical companies, biotechnology companies, and other commercial and academic research establishments.The Regulatory Affairs / Quality Assurance Associate will report directly to our Director of Regulatory Affairs / Quality Assurance.Overview:Support organization's Regulatory Affairs and Quality Assurance functions in multiple areas including documentation, compliance, audits and regulatory submissions.Job responsibilities:

  • Assists, coordinates or prepares US and international regulatory submissions.
  • Prepares or coordinates responses as requested by regulatory agencies or agents.
  • Prepares or maintains MDD technical files and related documentation.
  • Reviews clinical protocols to ensure appropriate collection of data to fulfill regulatory requirements.
  • Ensures all quality operating procedures (QOP), work instructions (WI), or policies are in compliance with EN ISO 13485:2016.
  • Reviews product promotional materials, labeling, records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Maintains knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Participates in internal audits, external supplier audits and MDSAP surveillance audits.
  • Other duties as assignedMinimum education/job experience:
    • Bachelor's degree in life sciences or engineering.
    • Minimum of 1 year experience in IVF, embryology, biotechnology or pharmaceutical industry.
    • Knowledge of electromechanical equipment and programmable systems preferredMinimum job skills/qualifications:
      • Strong verbal and written communication skills.
      • Detail-orientated with demonstrated problem solving skills and ability to multi-task.
      • Proficient in Microsoft office suite (Word, Excel, Outlook).

Keywords: Hamilton Thorne, Boston , Regulatory Affairs / Quality Assurance Associate, Other , Beverly, Massachusetts

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