Director of Regulatory Affairs and Quality Assurance

Director of Quality & Regulatory

US-based medical device manufacturer

Are you seeking a Director of Quality and regulatory position with a medical device manufacturer?

Do you have experience managing the Quality and Regulatory functions of an ISO 13485-certified manufacturer?

Do you enjoy ensuring an organization's products meet regulatory requirements and quality standards?

Do you want a Director of Quality & Regulatory position where you will oversee all aspects of quality management systems, regulatory compliance, and product development processes?

The Director of Quality & Regulatory is responsible for quality systems certification, quality assurance, quality control, quality engineering, regulatory compliance, submissions, strategy, product launch strategy, sustainability, and continual improvement activities across the entire product portfolio and organization for a diagnostic and surgical device manufacturer.

Responsibilities:

1. Regulatory Compliance:

Stay current with global regulatory requirements and medical device industry changes.

Develop strategies and implement processes to ensure compliance with applicable regulations and standards (e.g., FDA, EU MDR, ISO 13485).

Prepare and submit regulatory submissions, including 510(k) applications, CE marking applications, and other relevant documentation.

Interface with regulatory authorities during inspections, audits, and inquiries.

2. Quality Management Systems:

Establish and maintain an effective quality management system (QMS) to ensure compliance with relevant standards.

Develop and implement policies, procedures, and work instructions to govern quality processes throughout the organization.

Conduct internal audits and manage external audits by regulatory bodies and certification authorities.

Lead efforts to achieve and maintain ISO 13485 certification.

3. Product Development and Lifecycle Management:

Guide quality and regulatory requirements during product development and design control processes.

Collaborate with cross-functional teams to ensure products meet quality standards and regulatory requirements.

Review and approve design and manufacturing changes to ensure compliance with applicable regulations.

Oversee post-market surveillance activities, including complaint handling, adverse event reporting, and product recalls, if necessary.

4. Risk Management:

Implement and maintain a robust risk management process to identify and mitigate potential risks associated with products.

Review risk assessments, hazard analyses, and other related documents to ensure appropriate risk control measures are in place.

Drive continuous improvement in risk management processes based on industry best practices and regulatory guidelines.

5. Leadership and Team Management:

Build and lead a high-performing quality and regulatory team, providing guidance, coaching, and professional development opportunities.

Foster a culture of quality and regulatory compliance throughout the organization.

Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to align quality and regulatory goals.

Qualifications and Requirements:

Bachelors or advanced degree in a scientific, engineering, or related field.

In-depth knowledge of global medical device regulations and standards (e.g., FDA, EU MDR, ISO 13485).

Demonstrated experience in quality management systems, regulatory compliance, and product development within the medical devices industry.

Proven track record of successful regulatory submissions and interactions with regulatory authorities.

Strong understanding of risk management principles and practices.

Excellent leadership and people management skills.

Effective communication and interpersonal skills to collaborate with internal teams and external stakeholders.

Analytical mindset with the ability to drive data-driven decision-making.

Certifications such as RAC (Regulatory Affairs Certification) or CQE (Certified Quality Engineer) are preferred.

Location: Willoughby, Ohio

Compensation: The compensation package includes a competitive base salary, an annual bonus, profit sharing, and benefits.

Our client offers exceptional advancement potential for an ambitious person.

Company information: The company has excellent brand recognition, a reputation for quality products, and a commitment to exceptional customer experiences. Their products are distributed globally.

The timeframe to fill this search is as-soon-as-possible.