Director of Regulatory and Quality

Danvers, Massachusetts Permanent USD160,000 - USD180,000 per year View Job Description
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.
  • Leadership Opportunity within leading provider of Advanced Laser Systems
  • Increases in Organic Growth, Sales and Gross Profit over the past year

About Our Client

Our 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.

Job Description

The 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 metrics

A full job description will be sent after assessment of candidate's credentials.

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.

The Successful Applicant

The 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

What's on Offer

My 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.

Contact
Daniel Hall
Quote job ref
JN-012024-6312551

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Healthcare / Pharmaceutical
Location
Danvers
Contract Type
Permanent
Consultant name
Daniel Hall
Job Reference
JN-012024-6312551