Regulatory Affairs / Quality Assurance Associate Job Opening
Job Title: Regulatory Affairs / Quality Assurance Associate
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.
Support organization’s Regulatory Affairs and Quality Assurance functions in multiple areas including documentation, compliance, audits, and regulatory submissions.
- 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.
- 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.
- Participates in internal audits, external supplier audits and leads MDSAP surveillance audits.
- Coordinates recall or field corrective actions as necessary.
- Coordinates Import/Export/Customs activities.
- Develops and tracks quality metrics.
- Other duties as assigned.
Minimum education/job experience:
- Bachelor’s degree in life sciences or engineering.
- Minimum of 1 year quality management experience and 3 – 5 years’ experience in the Medical Device, biotechnology or pharmaceutical industry.
- EU MDD/MDR Auditor Certification, strongly preferred.
- Knowledge of electromechanical equipment and programmable systems preferred.
Minimum job skills/qualifications:
- Strong verbal and written communication skills.
- Detail-oriented with demonstrated problem solving skills and ability to multi-task.
- Proficient in Microsoft office suite (Word, Excel, Outlook).
Please email resume and cover letter to: employment [AT] hamiltonthorne [DOT] com.