Medical Device Regulatory Expert
hace 6 días
**Company Overview**
SGS is a leading global testing, inspection and certification company with a presence in over 2,600 offices and laboratories worldwide. Our mission is to enable a better, safer and more interconnected world.
**Salary:** $80,000 - $100,000 per annum
**Job Description:** As a Medical Device Regulatory Expert at SGS, you will play a crucial role in the conformity assessment process of medical devices. You will work closely with a team of clinicians and product reviewers to ensure that our clinical evaluation assessments comply with EU MDR regulations.
**Responsibilities:**
- Provide clinical oversight to ensure compliance with EU MDR regulations
- Review and scientifically challenge clinical data contained within clinical evaluations and investigations
- Coordinate and guide external clinical experts in clinical assessments and evaluate results
- Draw records and reports regarding clinical assessments and make recommendations to the notified body's decision maker
- Develop and update training packages for clinical experts and specialists
- Offer clinical input into client queries and meetings
**Qualifications:**
- A qualified physician (University degree - Medical Doctor) with further academic training in a clinically related area
- At least two years of experience in assessing clinical data for medical devices
- Fluent in English, reading and writing
**Benefits:**
- We offer a hybrid working environment
- Opportunity to work with a global leader in inspection, verification, testing, and certification
- Collaborative and inclusive work environment
- Competitive salary and benefits package
- Opportunities for professional growth and development
**Note:** This job description is based on the original content provided and may not reflect the actual requirements or details of the position. It is intended to provide an accurate representation of the job and its responsibilities.
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