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Head of Quality and Regulatory Affairs

2 months ago

Danvers, Massachusetts, United States Michael Page Full time

Position Overview

Reporting directly to the General Manager, the Head of Quality and Regulatory Affairs will be responsible for upholding and advancing the existing ISO 13485 standards, FDA cGMP regulations, and the Canadian Medical Devices Conformity Assessment System (CMDCAS). This role is integral to the Senior Management team, contributing to both daily operations and long-term strategic objectives.

Company Overview

Our client is a leader in the manufacturing and marketing of a diverse range of electronic products, consumables, and services that facilitate significant advancements in the Medical Device sector. They are committed to expanding their diverse customer base both nationally and internationally.

Key Responsibilities

The Head of Quality and Regulatory Affairs will undertake the following duties:

  • Serve as the Management Representative for the Quality Management System (QMS).
  • Lead the preparation of FDA submissions, including 510(k) applications, while collaborating with external consultants as necessary and defining critical design and development parameters alongside Product Development Teams.
  • Oversee internal audit processes and ensure timely resolution of any findings.
  • Facilitate and manage external audits, including those conducted by the FDA, MDSAP, and other regulatory bodies.
  • Provide comprehensive global regulatory support concerning labeling, promotional materials, product modifications, documentation, and marketing claims.
  • Ensure compliance with product registrations and certifications, offering support to authorized distributors.

Candidate Profile

The ideal candidate for the Head of Quality and Regulatory Affairs will possess:

  • A minimum of a Bachelor's degree.
  • At least 5 years of experience in the medical device industry.
  • Expertise in drafting FDA and other regulatory submissions, including Pre-submissions, 510(k), PMA, and Technical Files/Design Dossier.
  • Extensive knowledge of ISO 13485 and ISO 14971 standards.
  • A thorough understanding of FDA cGMP/Quality System Regulations (QSR), International Standards for Organization (ISO), Medical Device Single Audit Program (MDSAP), and EU Medical Device Regulation (2017/745).

Compensation and Benefits

Our client offers a competitive compensation package that includes:

  • A competitive base salary.
  • Bonus opportunities.
  • Equity participation in the company.
  • Flexible remote work options.
  • A comprehensive PTO plan.
  • 401k with company matching.

Michael Page is an equal opportunity employer and encourages applications from all qualified individuals, including minorities, women, the disabled, and protected veterans.