Director Regulatory Affairs and Quality Assurance
3 weeks ago
This role is responsible for ensuring my client's compliance with regulations and quality standards for medical devices. It combines two key areas: Regulatory Affairs (RA) and Quality Assurance (QA).
Key Responsibilities:
Regulatory Compliance:
Ensure adherence to FDA, CE, ISO and other relevant regulations.
Manage relationships with regulatory agencies.
Monitor regulatory changes and advise management of potential impacts.
Oversee regulatory submissions and approvals for my client's medical devices.
Quality Assurance:
Develop and implement quality processes (QMS) for design, manufacturing, and sterilization of my client's medical devices.
Manage supplier quality through audits and reviews.
Oversee complaint handling, reporting, and corrective actions for my client's medical devices.
Train employees on quality requirements.
Analyze quality data and identify improvement opportunities for my client's medical devices.
Other duties include:
Manage non-conforming products and corrective actions for my client.
Conduct technical onboarding for Original Equipment Manufacturers (OEMs) collaborating with my client.
Collaborate with various departments within my client's organization to achieve quality goals.
Qualifications:
Bachelor's degree in a related field (or equivalent experience).
In depth understanding of device sterilization processes.
Minimum 5 years of experience in Regulatory Affairs, Quality Assurance, or a combination of both, specifically in the medical device industry.
Strong knowledge of FDA regulations (including GMP), Medical Device Regulation (MDR), and ISO standards.
Excellent communication and collaboration skills.
Adaptability and resourcefulness for a fast-paced, small company environment.
Overall, this position plays a critical role in ensuring my client's medical devices meet regulatory requirements and are safe and effective for their intended use.
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