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.