Talent.com
Diese Stelle ist in deinem Land nicht verfügbar.
Quality Assurance & Regulatory Affairs Manager

Quality Assurance & Regulatory Affairs Manager

PharmiwebHamburg, DE
Vor 5 Tagen
Stellenbeschreibung

Job Description

Barrington James' QARA division are seeking a proactive and experienced Quality Assurance & Regulatory Affairs (QA / RA) Manager. This role is pivotal in maintaining and improving Quality Management System (QMS) and securing global market access through compliance with international regulations.

  • This opportunity is hybrid

To be considered for this Quality Assurance & Regulatory Affairs Manager :

Essential : 4+ years in the medical device industry in QARA., Fluent in English.

Desirable : MDD - MDR exposure, hands on experience technical file writing

Responsibilities.

  • Lead and manage all quality assurance activities, including maintaining ISO 13485 compliance.
  • Oversee the regulatory strategy for existing and new products, including EU MDR and FDA submissions.
  • Ensure continuous improvement of our QMS, handling internal and external audits.
  • Manage technical documentation, risk management, and CAPA processes.
  • Act as a point of contact with regulatory bodies and certification organizations.
  • Coordinate the preparation and submission of regulatory filings (CE Marking, 510(k), etc.).
  • Take part in the transition of paper to electronic Quality Management System

    • If this role is of interest, please apply or email [email protected] for more information.