Component Approval Process Manager

1 day ago


Oldham, Oldham, United Kingdom Molnlycke Health Care Full time
About Us

Mölnlycke Health Care is a leading provider of medical products and solutions. Our mission is to equip healthcare professionals with the tools they need to deliver exceptional care.

Role Overview

We are seeking a Component Approval Process Manager to join our team. As a key member of our global regulatory team, you will play a critical role in ensuring compliance with regulatory requirements and supporting the development of new medical devices.

  • You will be responsible for setting up, implementing, maintaining, and improving the component approval process.
  • Working closely with international business partners, you will focus on the APAC region.
  • You will provide expertise on regulatory issues related to component approval.
  • Effective communication with suppliers will be crucial to your success.
  • You will also update internal and external stakeholders with relevant data on component approval.
  • In addition, you will support ad-hoc development and improvement projects related to component approval.
Key Responsibilities

Your key responsibilities will include:

  • Developing and maintaining a deep understanding of regulatory requirements and industry standards.
  • Collaborating with cross-functional teams to ensure compliance and effective product development.
  • Providing expert advice on regulatory matters and identifying areas for process improvement.
  • Building strong relationships with international business partners and suppliers.
  • Communicating effectively with stakeholders to ensure seamless integration and deployment of approved components.
Requirements

To succeed in this role, you will need:

  • An understanding of the medical device or pharma industry with knowledge of MDD/MDR.
  • Regulatory affairs and/or QA background with good computer literacy skills.
  • Strong communication, negotiation, and networking skills.
  • A goal-oriented individual demonstrating accountability and initiative.
  • Previous experience with surgical products or customised procedure trays is beneficial.
  • First-hand use of SAP is highly desirable.
  • The ability to work as part of a small team and autonomously to deliver excellent tray production support.
What We Offer

We offer a competitive salary of approximately £40,000 per annum, with up to 10% annual bonus. Our benefits package includes a private pension with up to 10% company contribution, life assurance, income protection, and an Employee Assistance Programme. In addition, we offer flexible hybrid working: 2 days from home, 3 days from office.



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