Current Opportunities

Our client is a leading medical device company with a strong focus on cardiovascular implantable devices

We are looking for a full-time Director of Quality and Regulatory Affairs to join our team. The ideal candidate will have a strong background in regulatory approval processes, FDA submissions and approvals, ISO systems, and auditing. This role is critical in ensuring our products meet all necessary quality standards and regulatory requirements

• Regulatory Strategy and Compliance. Oversee the preparation and submission of FDA applications, including 510(k)s, PMAs, and IDEs. Oversee internal and external quality audits.

• Bachelor's degree in Nursing, Life Sciences, or a related field.
• Minimum of 3 years of experience in clinical research.
• Strong analytical skills and attention to detail.
• Proficiency in Microsoft Office Suite.
• Excellent communication and interpersonal skills.

Our client is a leading biotech company focused on developing innovative therapies. They are committed to maintaining the highest standards of regulatory compliance and quality assurance.

This remote position is perfect for a compliance expert who wants to work with a biotech company to ensure adherence to FDA regulations and global standards. You will lead efforts in regulatory compliance, ensuring all processes meet legal and industry requirements.

• Develop and implement regulatory compliance policies and procedures.
• Monitor and report on compliance with FDA regulations and global standards.
• Provide training and support to staff on regulatory compliance issues.
• Collaborate with cross-functional teams to ensure compliance in all aspects of operations.

• Bachelor's degree in Life Sciences, or a related field.
• Minimum of 3 years of experience in regulatory compliance.
• Strong analytical skills and attention to detail.
• Proficiency in Microsoft Office Suite.
• Excellent communication and interpersonal skills.

Our client is a leading biotech company focused on developing innovative therapies. They are committed to maintaining the highest standards of quality assurance and regulatory compliance.

We are looking for a full-time Senior Quality Assurance Manager to join our team. The ideal candidate will have a strong understanding of quality assurance processes and methodologies, as well as experience in the biotech or pharmaceutical industry.

• Develop and implement quality assurance policies and procedures.
• Conduct regular audits and inspections to ensure compliance with industry standards.
• Collaborate with cross-functional teams to identify and resolve quality issues.
• Provide training and support to staff on quality assurance best practices.

• Bachelor's degree in Engineering, Construction Management, or a related field.
• Minimum of 3 years of experience in quality assurance in the biotech or pharmaceutical industry.
• Strong analytical skills and attention to detail.
• Proficiency in Microsoft Office Suite.
• Excellent communication and interpersonal skills.