Vice President of Regulatory and Quality Management

2 weeks ago


Danvers, Massachusetts, United States Michael Page Full time

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 pivotal role is part of the Senior Management team, contributing to both daily operations and long-term strategic goals.

Client Overview

Our client is a leader in the manufacturing and marketing of innovative electronics, consumables, and services that drive advancements in the Medical Device sector. They boast a diverse and expanding portfolio of clients, both nationally and internationally.

Key Responsibilities

The Head of Quality and Regulatory Affairs will:

  • 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 criteria alongside Product Development Teams.
  • Oversee internal audit initiatives and ensure timely resolution of audit findings.
  • Facilitate and manage external audits, including those conducted by the FDA, MDSAP, and other notified bodies.
  • Provide comprehensive global regulatory support concerning labeling, promotional materials, product modifications, documentation, and marketing claims.
  • Ensure compliance with product registrations and certifications, while 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 preparing FDA and other regulatory submissions, including Pre-submissions, 510(k), PMA, and Technical Files/Design Dossier.
  • In-depth 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, which includes:

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

Michael Page is committed to promoting diversity and inclusion in the workplace. We encourage applications from all qualified individuals, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or any other status protected by applicable law.



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