Cco - Danvers, MA, United States - Michael Page

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.

Client Details

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.
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.
Profile
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
Job 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.

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.