About Us :
Our 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.
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