Medical Device Compliance Specialist
5 days ago
We are SGS – the world's leading testing, inspection and certification company. Our Vision: Enable a better, safer and more interconnected world.
About the Role:
In this critical temporary position, you will play a key part in ensuring compliance with Notified Body requirements for medical device certifications as a Contract Worksheet Approver. You will serve as a trusted reviewer of technical documentation submitted by our Sales team to guarantee regulatory adherence and uphold SGS's commitment to excellence. Comprehensive training on SGS policies and procedures will be provided to set you up for success in this role.
Main Responsibilities:
- Evaluate Certification Requests: Determine whether third-party service product certification requests pertain to medical devices and align with applicable regulatory frameworks.
- Document Review: Examine and approve Medical Device Contract Worksheets and related documents to ensure compliance with MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation).
- Scope Validation: Verify that certification requests are within the scope of our Notified Body's capabilities.
- Audit Team Allocation: Approve audit team competency assignments using predefined auditor codes for required competencies.
- Regulatory Compliance: Ensure strict adherence to Notified Body procedures and accurate completion of all required documentation.
- Decision-Making Support: Facilitate prompt and accurate acceptance or refusal of client projects while safeguarding SGS's integrity.
- Ongoing Documentation Review: Assess submitted pre-audit questionnaires, change requests, vigilance forms, and other key documents.
- Client and Stakeholder Collaboration: Partner with affiliates to deliver timely, responsive service to internal and external clients, prioritizing customer satisfaction.
- Leadership Support: Assist the Global Medical Device Certification Manager in effectively managing certification requests and associated processes.
Contract Details:
- Duration: Temporary role covering a maternity leave.
- Training: Comprehensive onboarding and training on SGS policies and procedures to ensure a seamless transition.
Your Background:
- Educational Background: Bachelor's degree (or higher) in Engineering, Biomedical Sciences, or a related scientific discipline.
- Industry Expertise: Proven experience working with medical devices, with knowledge of regulatory frameworks and product standards.
- Language Proficiency: Fluent in English; additional languages are an advantage.
- Attention to Detail: Strong analytical skills and a meticulous approach to document review and regulatory compliance.
- Teamwork and Communication: Ability to collaborate effectively with cross-functional teams while maintaining a client-focused mindset.
Benefits:
- Global and stable company, world leader in the TIC industry.
- Flexible schedule with remote work options.
- Access to SGS University and Campus for continuous learning.
- Multinational environment where you will work with colleagues from multiple continents.
- Competitive salary: $80,000 - $100,000 per year, depending on your experience and qualifications.
Join SGS: At SGS, we foster an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide opportunities to learn, grow your expertise, and fulfill your potential.
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