RA/QA manager

Position Overview:

The QA/RA Manager will oversee and manage the quality assurance and regulatory affairs functions within the company. This role is responsible for ensuring that our medical device meets all regulatory requirements and maintains the highest standards of quality throughout its lifecycle. The ideal candidate will have substantial experience in the medical device industry, particularly with invasive devices, and possess a thorough understanding of regulatory compliance and quality management systems.

Responsibilities:

1. Develop, implement, and maintain quality management systems (QMS) in accordance with ISO 13485 and 21 CFR Part 820 (QSR) and to ensure compliance with the relevant ISO standards, guidelines and FDA guidance.
2. Prepare and maintain regulatory documentation, including product registrations, compliance reports and technical files, collaborating with R&D engineers to create and maintain DHF documents.
3. Ensure regulatory submissions are prepared, reviewed, and submitted to regulatory agencies in a timely manner.
4. Manage regulatory and quality strategies for product development, approval, and lifecycle management.
5. Collaborate with R&D and manufacturing teams to address quality issues and drive continuous improvement.
6. Stay current with changes in regulatory requirements and guidelines and communicate relevant updates to the team.

Qualifications:

·      Bachelor’s degree in Engineering, Life Sciences, or a related field; a degree from a renowned university is preferred.

·      Minimum of 6 years of experience in Quality Assurance and Regulatory Affairs within the medical device industry, with at least 3 years of experience specifically with invasive medical devices.

·      Strong knowledge of ISO standards and international regulatory requirements.

·      Proven track record of successfully managing regulatory submissions and maintaining compliance with quality standards.

·      Excellent analytical, problem-solving, and project management skills.

·      Effective communication skills, both written and verbal, with the ability to interact with regulatory agencies and internal stakeholders.