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Director of Regulatory and Quality

1 month ago

Danvers, United States Michael Page Full time

  • Leadership Opportunity within leading provider of Electronic Medical Devices
  • Increases in Organic Growth, Sales and Gross Profit over the pastthree years

    About Our Client

    Our client manufactures and markets various electronics, consumables, and services that enable breakthroughs in within their Medical Device market. They have a growing diversified portfolio of customers which they are continuing to expand both domestically and internationally.

    Job Description

    The responsibilities of the Director of Quality and Regulatory are:

  • Functions as the Management Representative for the Quality Management System (QM)
Acts as lead preparer of FDA filings such as 510(k) applications, coordinates with outside consultants as required, and identifies critical design and development criteria in conjunction with Product Development TeamsOversees internal audit programs and follows up in a timely fashion on internal audit findings. ·Leads and hosts external audits (i.e., FDA, MDSAP, notified bodies, vendor audits, etc.).Provides Global regulatory support relating to labeling, promotional material, product changes, documentation, and marketing claims.Manages compliance of product registrations, certifications, and support provided to authorized distributors.

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 fieldExpertise and proficiency authoring FDA and other regulatory submissions (Pre-submissions, 510(k), PMA, Technical Files/Design Dossier, etc.).Extensive knowledge of ISO 13485 and ISO 14971.Thorough understanding/experience with FDA cGMP/Quality System Regulations (QSR), International Standards for Organization (ISO), Medical Device Single Audit Program (MDSAP), EU Medical Device Regulation (2017/745)

If interested, please apply using the link below. Qualified Applicant will be contacts within 24-48 hours of submission.

What's on Offer

My client can offer the following:

Competitive base salaryBonus potentialEquity within the Company Flexibility to work remotely Competitive PTO Plan 401k Company match