Associate Ra Specialist
2 months ago
**About the Company**:
**Responsibilities**:
- Assist with the competition on RA submissions.
- Assist with global registrations.
- Assist with distributor registrations.
- Liaise with engineering, quality, operations and commercial departments.
- Prepare and maintain EU MDR, UK MDR and US 510K technical documents.
- Creation and maintenance of RA processes.
- Assisting with design and implementation of regulatory tools.
- Training.
- Assist with clinical, post market, risk, sterilization, biocompatibility and labelling documents.
- Assist with technical and quality related issues.
- Participate in root cause analysis and investigations.
- Assist with validation and qualification requirements.
**Requirements**:
- Degree in a relevant Scientific or Engineering discipline.
- Experience working in the medical device industry.
- Understanding of ISO13485, EU MDR, UK MDR, MD SAP and or US 21 CFR820.
- Excellent written and verbal communication skills.
- Technical writing and project management experience.
- Ability to mange time effectively.
- Excellent organizational skills.
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