Regulatory Affairs / Quality Assurance Associate
Company: Hamilton Thorne
Posted on: June 25, 2022
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
- Prepares or coordinates responses as requested by regulatory
agencies or agents.
- Prepares or maintains MDD technical files and related
- 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
- 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,
Keywords: Hamilton Thorne, Boston , Regulatory Affairs / Quality Assurance Associate, Other , Beverly, Massachusetts
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