ISO 13485, FDA CFR21 820, MDSAP and CE MDD and MDR Specialist

3 weeks ago

Calabasas, United States Medical Device Company Full time $30 - $33
Job DescriptionJob Description

We are seeking a detail-oriented Regulatory Affairs Specialist to join our team. The ideal candidate will be responsible for ensuring compliance with all regulations and laws pertaining to our 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, 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

 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

·

 

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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