Component Approval Process Manager
1 day ago
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 OverviewWe 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.
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.
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.
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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