Quality Management System Specialist
2 weeks ago
We are seeking a detail-oriented Regulatory Affairs Specialist to join our team. The ideal candidate will be responsible for ensuring our Quality Management System and documentation is in compliance with ISO 13485, CFR 21 Part 820, MDSAP and CDE MDR regulations and laws pertaining to our Medical Device industry.
Responsibilities
- Manage regulatory submissions and approvals for new products and changes to existing products
- Be in charge of Quality Management System, SOPs, Quality Procedures and documentation.
- Stay current on FDA CFR 21 Part 820, CE MDR, MDSAP, ISO 13485 regulations and guidelines to ensure compliance
- Coordinate and support regulatory inspections and audits
- Develop and implement regulatory strategies for product approvals
- Collaborate with cross-functional teams on regulatory issues
- Conduct research on regulatory requirements and provide guidance to the organization
- Keep track of Critical and Non-Critical Suppliers and agreements
- Post Market Surveillance
- Customer Feedback
- Internal Audits
- Track trends and create performance matrices
- Employee Training logs regarding the QMS
- Keep track of calibration Logs
- Make sure the QMS is being followed and DHR and DMR are kept up to date
- Make sure all documentations, procedures and records are kept up to date and all employees are following procedures.
.Experience
- Bachelor's degree in a related field, or Life Sciences
- Proven experience in regulatory affairs within the pharmaceutical or medical device industry
- Knowledge of manufacturing controls, Clinical trials, Quality assurance, Project management, and Compliance management
- Familiarity with FDA, CE MDR, MDSAP, ISO 13485 regulations and guidelines
- Strong writing and verbal skills and attention to detail
This is an excellent opportunity for a motivated individual looking to advance their career in regulatory affairs within a dynamic and growing organization.
Job Types: Full-time, Part-time
Pay: $33.00 per hour
Expected hours: 40 per week
Benefits:
- Employee stock purchase plan
Schedule:
- Full Time in person 8 hours 8:00 AM to 5:00 PM
Experience:
- FDA and CE regulations: 2 years (Preferred)
Ability to Commute:
- Calabasas, CA 91302 (Required)
Ability to Relocate:
- Calabasas, CA 91302: Relocate before starting work (Required)
Work Location: In person
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Company DescriptionMicro Medical Devices Inc. is a state of the art Ophthalmic Instrument medical Device Company dedicated to bring Eyecare health service devices to a worldwide diverse demographics. We serve medical professionals and world mission groups in providing eye care services to those in need.Company DescriptionMicro Medical Devices Inc. is a state of the art Ophthalmic Instrument medical Device Company dedicated to bring Eyecare health service devices to a worldwide diverse demographics. We serve medical professionals and world mission groups in providing eye care services to those in need.
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