Medical Device Regulatory Specialist
1 day ago
Mölnlycke Health Care is a world-leading medical products and solutions company. We equip healthcare professionals to achieve the best patient, clinical, and economic outcomes.
Salary and BenefitsWe 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.
Job DescriptionGlobal Component Approval Specialist
Help us equip medical professionals with solutions to improve patient outcomes while building a successful career with real purpose.
- Set up, implement, maintain, and improve the component approval process.
- Maintain international business relationships, focusing on the APAC region.
- Support regulatory issues related to component approval for compliance, understanding, and involvement.
- Ensure accurate communication with suppliers in the component approval process.
- Update internal and external stakeholders with relevant data on component approval.
- Support ad-hoc development and improvement projects related to component approval.
We are looking for a candidate with:
- 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 flexible hybrid working: 2 days from home, 3 days from office.
Diversity and InclusionDiversity fuels innovation, creativity, and problem-solving. At Mölnlycke, diversity is not just a vision, but our strength. We foster an inclusive workplace that values and celebrates the power of diversity.
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