We are seeking a highly experienced Regulatory Affairs and Quality Manager to oversee and manage all quality assurance and regulatory affairs functions within our medical device company. The ideal candidate will have a strong background in the medical device industry, particularly with invasive devices, and a deep understanding of regulatory compliance and quality management systems.

Responsibilities:

• Reports to: VP of R&D
• Develop, implement, and maintain quality management systems (QMS) in accordance with ISO 13485 and 21 CFR Part 820.
• Prepare and maintain regulatory documentation, including product registrations, compliance reports, and technical files.
• Ensure timely submission of regulatory documents to regulatory agencies.
• Manage regulatory and quality strategies for product development, approval, and lifecycle management.
• Collaborate with R&D and manufacturing teams to address quality issues and improve processes.
• Stay updated on regulatory changes and communicate updates to the team.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 6+ years of experience in Quality Assurance and Regulatory Affairs in the medical device industry, with at least 3 years of experience with invasive devices.
• Strong knowledge of ISO standards and international regulatory requirements.
• Proven track record of successful regulatory submissions and compliance maintenance.
• Excellent analytical, problem-solving, and project management skills.
• Effective written and verbal communication skills.