​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:

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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.