BioTalent Ltd
RA/QA Specialist
BioTalent Ltd, San Diego, California, United States, 92189
About Us:
My Client is a leading innovator in the medical device industry, dedicated to developing and manufacturing cutting-edge Class III implantable medical devices. We are committed to improving patient lives through our innovative solutions.
Job Description:
As an RA/QA Specialist, you will play a critical role in ensuring the quality and regulatory compliance of our medical devices. You will be responsible for a wide range of activities, including:
Key Responsibilities:
Regulatory Affairs:
Support the development and maintenance of regulatory strategies for new and existing products.
Prepare and submit regulatory submissions to the FDA and other relevant regulatory authorities, including 510(k)s, IDEs, and PMA applications.
Monitor and interpret regulatory requirements and standards, such as 21 CFR Part 820, ISO 13485, and EU MDR.
Conduct regulatory research and analysis to identify potential risks and compliance issues.
Participate in regulatory audits and inspections.
Quality Assurance:
Support the implementation and maintenance of the Quality Management System (QMS).
Conduct internal audits to assess compliance with QMS requirements.
Participate in investigations of product complaints and non-conformances.
Review and approve design control documents, such as design history files, risk analyses, and verification and validation plans.
Support the development and execution of quality plans and procedures.
Other Responsibilities:
Assist in the development and maintenance of technical documentation, such as design specifications, test protocols, and user manuals.
Collaborate with cross-functional teams, including engineering, manufacturing, and clinical affairs, to ensure product quality and regulatory compliance.
Stay up-to-date on industry trends and regulatory changes.
Qualifications and Skills:
Bachelor's degree in engineering, science, or a related field.
Minimum of 2 years of experience in the medical device industry, with a focus on Class III implantable devices.
Strong understanding of FDA regulations, ISO 13485, and other relevant standards.
Excellent written and verbal communication skills.
Strong attention to detail and organizational skills.
Ability to work independently and as part of a team.
Benefits:
We offer a competitive salary and benefits package, including:
Health, dental, and vision insurance
401(k) with company match
Paid time off
Flexible work arrangements
If you are a highly motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply.
#J-18808-Ljbffr
My Client is a leading innovator in the medical device industry, dedicated to developing and manufacturing cutting-edge Class III implantable medical devices. We are committed to improving patient lives through our innovative solutions.
Job Description:
As an RA/QA Specialist, you will play a critical role in ensuring the quality and regulatory compliance of our medical devices. You will be responsible for a wide range of activities, including:
Key Responsibilities:
Regulatory Affairs:
Support the development and maintenance of regulatory strategies for new and existing products.
Prepare and submit regulatory submissions to the FDA and other relevant regulatory authorities, including 510(k)s, IDEs, and PMA applications.
Monitor and interpret regulatory requirements and standards, such as 21 CFR Part 820, ISO 13485, and EU MDR.
Conduct regulatory research and analysis to identify potential risks and compliance issues.
Participate in regulatory audits and inspections.
Quality Assurance:
Support the implementation and maintenance of the Quality Management System (QMS).
Conduct internal audits to assess compliance with QMS requirements.
Participate in investigations of product complaints and non-conformances.
Review and approve design control documents, such as design history files, risk analyses, and verification and validation plans.
Support the development and execution of quality plans and procedures.
Other Responsibilities:
Assist in the development and maintenance of technical documentation, such as design specifications, test protocols, and user manuals.
Collaborate with cross-functional teams, including engineering, manufacturing, and clinical affairs, to ensure product quality and regulatory compliance.
Stay up-to-date on industry trends and regulatory changes.
Qualifications and Skills:
Bachelor's degree in engineering, science, or a related field.
Minimum of 2 years of experience in the medical device industry, with a focus on Class III implantable devices.
Strong understanding of FDA regulations, ISO 13485, and other relevant standards.
Excellent written and verbal communication skills.
Strong attention to detail and organizational skills.
Ability to work independently and as part of a team.
Benefits:
We offer a competitive salary and benefits package, including:
Health, dental, and vision insurance
401(k) with company match
Paid time off
Flexible work arrangements
If you are a highly motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply.
#J-18808-Ljbffr