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Quality Assurance & Regulatory Affairs Coordinator
2023-06-28
2023-10-25
Employment Type:
Contract
Industry: Professional/Administrative
Job Number: 59184
Office Location: Salem
Job Description
Our Client is Northern Massachusetts is a Medical Device company that is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. Their products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest.
The Quality Assurance and Regulatory Affairs Coordinator will be responsible for complaint handling and Regulatory reporting process.
Skill Requirements:
Required/Preferred Education and Experience:
The Quality Assurance and Regulatory Affairs Coordinator will be responsible for complaint handling and Regulatory reporting process.
- Prepare and maintain regulatory documentation.
- Coordinate and maintain closed service request system.
- Coordinate & maintain system for storage and retrieval of active service requests for complaints.
- Provide support for coordinators and technicians.
- Communicate and correspond with customers.
Skill Requirements:
- Have basic computer skills in a MS Windows environment.
- Versatile
- Organizing skills
- Have above average Oral and Writing communication skills.
- Ability to communicate and work effectively within a multi-disciplined organization.
- Knowledge of FDA Regulations or experience in a medical device environment.
Required/Preferred Education and Experience:
- High School Diploma/GED or equivalent work experience
- Preferred certification in the Regulatory related to complaint handling
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