qa specialist - device vigilance
Posted 1 week ago by 1772790325
Negotiable
Outside
Hybrid
cambridge, massachusetts (remote)
Summary: The Quality Assurance Specialist - Device Vigilance is responsible for ensuring regulatory compliance in medical device complaint handling and safety reporting. This role involves conducting reportability assessments and authoring Medical Device Reports (MDRs) to meet global vigilance requirements and reporting timelines. The position offers a combination of on-site and remote work options.
Key Responsibilities:
- Ensure regulatory compliance for medical device complaint handling and safety reporting.
- Conduct reportability assessments.
- Author Medical Device Reports (MDRs) to regulatory authorities.
- Adhere to global vigilance requirements and strict reporting timelines.
Key Skills:
- Experience in quality assurance and regulatory compliance.
- Knowledge of medical device reporting and safety regulations.
- Strong analytical and assessment skills.
- Excellent written communication skills for report writing.
Salary (Rate): £54,000 yearly
City: Cambridge
Country: United States
Working Arrangements: hybrid
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
job summary: Quality Assurance Specialist - Device Vigilance
Location: On-site & Remote
About the Role
The Quality Assurance Specialist - Device Vigilance ensures regulatory compliance for medical device complaint handling and safety reporting. This role conducts reportability assessments and authors Medical Device Reports (MDRs) to regulatory authorities, ensuring adherence to global vigilance requirements and strict reporting timelines.
Key Responsibili