Hobson Prior is seeking a Regulatory and Quality Assurance Manager to ensure products meet necessary regulations and maintain high-quality standards. The successful candidate will focus on compliance, quality management, and continuous improvement. This role requires quick adaptation and effective communication with regulatory bodies.

Applicants must have legal authorization to work in the United States.

Key Responsibilities:

• Regulatory Compliance: Ensure that all products comply with relevant regulations (e.g., FDA, EU MDR, ISO 13485) and are properly documented.
• Quality Management: Develop, implement, and maintain Quality Management Systems (QMS) in accordance with regulatory standards.
• Audits and Inspections: Prepare for and manage internal and external audits, including inspections by regulatory agencies.
• Documentation: Oversee the preparation, review, and submission of regulatory documents, including technical files, risk assessments, and clinical evaluations.
• Training: Provide training to staff on regulatory requirements and quality assurance practices.
• Risk Management: Identify and mitigate potential risks associated with product development and manufacturing processes.
• Continuous Improvement: Lead continuous improvement initiatives to enhance product quality and regulatory compliance.
• Liaison: Act as the primary point of contact with regulatory bodies and represent the company in regulatory discussions and negotiations.

Qualifications:

• Bachelor's degree in a related field (e.g., Biomedical Engineering, Life Sciences, Quality Management).
• Minimum of 5 years of experience in quality assurance and regulatory affairs within the medical device industry.
• In-depth knowledge of FDA regulations, EU MDR, ISO 13485, and other relevant standards.
• Strong understanding of Quality Management Systems (QMS) and risk management principles.
• Excellent communication, leadership, and project management skills.
• Ability to work effectively in a fast-paced, dynamic environment.

For more information, please contact Toby Shelton.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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