Director of Regulatory and Quality

Company: Michael Page
Location: Danvers
Posted on: September 29, 2024

Job Description:

Reporting into the General manager, The Director of Quality & Regulatory will maintain and enhance the current ISO 13485, FDA cGMP and Canadian Medical Devices Conformity Assessment System (CMDCAS), Complaint system, and Quality Management System (QMS). The role is part of the Senior Management team and helps drive day-to-day activities as well as strategic initiatives. Client DetailsOur 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.DescriptionThe 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 Teams
• Oversees internal audit programs and follows up in a timely fashion on internal audit findings.
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• 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. ProfileThe 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
  • Expertise 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. Job OfferMy client can offer the following:
    • Competitive base salary
    • Bonus potential
    • Equity within the Company
    • Flexibility to work remotely
    • Competitive PTO Plan
    • 401k Company match 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.

Keywords: Michael Page, Salem , Director of Regulatory and Quality, Executive , Danvers, Massachusetts