QA/RA Manager

Exero Medical, a pioneering startup at the forefront of innovation in implanted diagnostic devices, is seeking a skilled QA/RA Manager to lead our Quality Assurance and Regulatory Affairs efforts. Our company is in the clinical stage, actively preparing its FDA submission after receiving Breakthrough Device Designation.

 Key Responsibilities:

Regulatory Affairs (RA)

 Lead all RA activities in the company:

o  Compile and submit regulatory submissions, monitor submission status and respond to regulatory authorities’ queries.

o  Ensure timely registration and maintenance of product approvals in target markets.

o  Review product labeling, packaging, and promotional materials for regulatory compliance.

o  Monitor and report adverse events and field safety corrective actions.

o  Conduct periodic reviews and updates of regulatory files and technical documentation

o  Maintain up-to-date knowledge of global regulations and standards.

Quality Assurance (QA)

Lead all QA activities in the company:

o  Develop and Maintain Quality Management Systems (QMS)

o  Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards.

o  Establish, document, implement, and maintain QMS processes and procedures.

o  Conduct Internal and External Audits

o  Manage Non-Conformances and CAPAs

o  Supplier Quality Management

o  Document Control and Change Management:

o  Training and Education

Cross-Functional Collaboration

o     Work closely with R&D, clinical, manufacturing, marketing, and other departments to integrate quality and regulatory requirements throughout the product lifecycle.

o  Provide guidance during design control, risk management, and validation activities.

Skills and Competencies

• Strong knowledge of medical device regulations and standards (e.g., FDA, ISO, MDR, etc.).
• Excellent organizational and communication skills.
• Analytical and problem-solving abilities.
• Detail-oriented and able to manage multiple tasks and priorities.
• Proficient in QMS software and tools.
• Hands on while being strategist.

Qualifications

• Bachelor’s  degree in engineering, life sciences, or a related field. Advanced degree preferred.
• 5+  years of QA/RA experience in the medical device industry.
• Hands-on experience in preparing and submitting FDA/ CE regulatory filings.
• Experience working with implantable diagnostic devices is an advantage.
• Certification in quality or regulatory affairs (e.g., RAPS, ASQ) is an advantage.